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Article ; Online: Bayesian deep learning outperforms clinical trial estimators of intracerebral and intraventricular hemorrhage volume.

Sharrock, Matthew F / Mould, W Andrew / Hildreth, Meghan / Ryu, E Paul / Walborn, Nathan / Awad, Issam A / Hanley, Daniel F / Muschelli, John

Journal of neuroimaging : official journal of the American Society of Neuroimaging

2022 Volume 32, Issue 5, Page(s) 968–976

Abstract: Background and purpose: Intracerebral hemorrhage (ICH) and intraventricular hemorrhage (IVH) clinical trials rely on manual linear and semi-quantitative (LSQ) estimators like the ABC/2, modified Graeb and IVH scores for timely volumetric estimation from ...

Abstract	Background and purpose: Intracerebral hemorrhage (ICH) and intraventricular hemorrhage (IVH) clinical trials rely on manual linear and semi-quantitative (LSQ) estimators like the ABC/2, modified Graeb and IVH scores for timely volumetric estimation from CT. Deep learning (DL) volumetrics of ICH have recently approached the accuracy of gold-standard planimetry. However, DL and LSQ strategies have been limited by unquantified uncertainty, in particular when ICH and IVH estimates intersect. Bayesian deep learning methods can be used to approximate uncertainty, presenting an opportunity to improve quality assurance in clinical trials. Methods: A DL model was trained to simultaneously segment ICH and IVH using diagnostic CT data from the Minimally Invasive Surgery Plus Alteplase for ICH Evacuation (MISTIE) III and Clot Lysis: Evaluating Accelerated Resolution of IVH (CLEAR) III clinical trials. Bayesian uncertainty approximation was performed using Monte-Carlo dropout. We compared the performance of our model with estimators used in the CLEAR IVH and MISTIE II trials. The reliability of planimetry, DL, and LSQ volumetrics in the setting of high ICH and IVH intersection is quantified using consensus estimates. Results: Our DL model produced volume correlations and median Dice scores of .994 and .946 for ICH in MISTIE II, and .980 and .863 for IVH in CLEAR IVH, respectively, outperforming LSQ estimates from the clinical trials. We found significant linear relationships between ICH uncertainty, Dice scores (r = -.849), and relative volume difference (r = .735). Conclusion: In our validation clinical trial dataset, DL models with Bayesian uncertainty approximation provided superior volumetric estimates to LSQ methods with real-time estimates of model uncertainty.
MeSH term(s)	Bayes Theorem ; Cerebral Hemorrhage/diagnostic imaging ; Cerebral Hemorrhage/surgery ; Clinical Trials as Topic ; Deep Learning ; Humans ; Reproducibility of Results ; Tissue Plasminogen Activator/therapeutic use
Chemical Substances	Tissue Plasminogen Activator (EC 3.4.21.68)
Language	English
Publishing date	2022-04-17
Publishing country	United States
Document type	Journal Article ; Research Support, N.I.H., Extramural
ZDB-ID	1071724-9
ISSN	1552-6569 ; 1051-2284
ISSN (online)	1552-6569
ISSN	1051-2284
DOI	10.1111/jon.12997
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Zs.A 3211: Show issues

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Article ; Online: Clinical Trial Protocol for BEACH: A Phase 2a Study of MW189 in Patients with Acute Nontraumatic Intracerebral Hemorrhage.

Avadhani, Radhika / Ziai, Wendy C / Thompson, Richard E / Mould, W Andrew / Lane, Karen / Nanni, Angeline / Iacobelli, Michael / Sharrock, Matthew F / Sansing, Lauren H / Van Eldik, Linda J / Hanley, Daniel F

Neurocritical care

2023 Volume 40, Issue 2, Page(s) 807–815

Abstract: Patients with acute spontaneous intracerebral hemorrhage (ICH) develop secondary neuroinflammation and cerebral edema that can further damage the brain and lead to increased risk of neurologic complications. Preclinical studies in animal models of acute ... ...

Abstract	Patients with acute spontaneous intracerebral hemorrhage (ICH) develop secondary neuroinflammation and cerebral edema that can further damage the brain and lead to increased risk of neurologic complications. Preclinical studies in animal models of acute brain injury have shown that a novel small-molecule drug candidate, MW01-6-189WH (MW189), decreases neuroinflammation and cerebral edema and improves functional outcomes. MW189 was also safe and well tolerated in phase 1 studies in healthy adults. The proof-of-concept phase 2a Biomarker and Edema Attenuation in IntraCerebral Hemorrhage (BEACH) clinical trial is a first-in-patient, multicenter, randomized, double-blind, placebo-controlled trial. It is designed to determine the safety and tolerability of MW189 in patients with acute ICH, identify trends in potential mitigation of neuroinflammation and cerebral edema, and assess effects on functional outcomes. A total of 120 participants with nontraumatic ICH will be randomly assigned 1:1 to receive intravenous MW189 (0.25 mg/kg) or placebo (saline) within 24 h of symptom onset and every 12 h for up to 5 days or until hospital discharge. The 120-participant sample size (60 per group) will allow testing of the null hypothesis of noninferiority with a tolerance limit of 12% and assuming a "worst-case" safety assumption of 10% rate of death in each arm with 10% significance and 80% power. The primary outcome is all-cause mortality at 7 days post randomization between treatment arms. Secondary end points include all-cause mortality at 30 days, perihematomal edema volume after symptom onset, adverse events, vital signs, pharmacokinetics of MW189, and inflammatory cytokine concentrations in plasma (and cerebrospinal fluid if available). Other exploratory end points are functional outcomes collected on days 30, 90, and 180. BEACH will provide important information about the utility of targeting neuroinflammation in ICH and will inform the design of future larger trials of acute central nervous system injury.
MeSH term(s)	Adult ; Humans ; Brain Edema/etiology ; Brain Edema/complications ; Neuroinflammatory Diseases ; Cerebral Hemorrhage/complications ; Edema/complications ; Treatment Outcome ; Randomized Controlled Trials as Topic ; Multicenter Studies as Topic ; Clinical Trials, Phase II as Topic ; Piperazines ; Pyridazines ; Pyridines
Chemical Substances	TT-301 (CY416F5NSK) ; Piperazines ; Pyridazines ; Pyridines
Language	English
Publishing date	2023-11-02
Publishing country	United States
Document type	Clinical Trial Protocol ; Journal Article
ZDB-ID	2381896-7
ISSN	1556-0961 ; 1541-6933
ISSN (online)	1556-0961
ISSN	1541-6933
DOI	10.1007/s12028-023-01867-2
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Zs.A 6538: Show issues

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Article ; Online: 3D Deep Neural Network Segmentation of Intracerebral Hemorrhage: Development and Validation for Clinical Trials.

Sharrock, Matthew F / Mould, W Andrew / Ali, Hasan / Hildreth, Meghan / Awad, Issam A / Hanley, Daniel F / Muschelli, John

Neuroinformatics

2020 Volume 19, Issue 3, Page(s) 403–415

Abstract: Intracranial hemorrhage (ICH) occurs when a blood vessel ruptures in the brain. This leads to significant morbidity and mortality, the likelihood of which is predicated on the size of the bleeding event. X-ray computed tomography (CT) scans allow ... ...

Abstract	Intracranial hemorrhage (ICH) occurs when a blood vessel ruptures in the brain. This leads to significant morbidity and mortality, the likelihood of which is predicated on the size of the bleeding event. X-ray computed tomography (CT) scans allow clinicians and researchers to qualitatively and quantitatively diagnose hemorrhagic stroke, guide interventions and determine inclusion criteria of patients in clinical trials. There is no currently available open source, validated tool to quickly segment hemorrhage. Using an automated pipeline and 2D and 3D deep neural networks, we show that we can quickly and accurately estimate ICH volume with high agreement with time-consuming manual segmentation. The training and validation datasets include significant heterogeneity in terms of pathology, such as the presence of intraventricular (IVH) or subdural hemorrhages (SDH) as well as variable image acquisition parameters. We show that deep neural networks trained with an appropriate anatomic context in the network receptive field, can effectively perform ICH segmentation, but those without enough context will overestimate hemorrhage along the skull and around calcifications in the ventricular system. We trained with all data from a multi-center phase II study (n = 112) achieving a best mean and median Dice coefficient of 0.914 and 0.919, a volume correlation of 0.979 and an average volume difference of 1.7 ml and root mean squared error of 4.7 ml in 500 out-of-sample scans from the corresponding multi-center phase III study. 3D networks with appropriate anatomic context outperformed both 2D and random forest models. Our results suggest that deep neural network models, when carefully developed can be incorporated into the workflow of an ICH clinical trial series to quickly and accurately segment ICH, estimate total hemorrhage volume and minimize segmentation failures. The model, weights and scripts for deployment are located at https://github.com/msharrock/deepbleed . This is the first publicly available neural network model for segmentation of ICH, the only model evaluated with the presence of both IVH and SDH and the only model validated in the workflow of a series of clinical trials.
MeSH term(s)	Brain ; Cerebral Hemorrhage/diagnostic imaging ; Humans ; Image Processing, Computer-Assisted ; Neural Networks, Computer ; Skull ; Tomography, X-Ray Computed
Language	English
Publishing date	2020-09-27
Publishing country	United States
Document type	Clinical Trial, Phase II ; Journal Article ; Research Support, N.I.H., Extramural
ZDB-ID	2111941-7
ISSN	1559-0089 ; 1539-2791
ISSN (online)	1559-0089
ISSN	1539-2791
DOI	10.1007/s12021-020-09493-5
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Zs.A 5816: Show issues

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Article ; Online: Retrospective Methods Analysis of Semiautomated Intracerebral Hemorrhage Volume Quantification From a Selection of the STICH II Cohort (Early Surgery Versus Initial Conservative Treatment in Patients With Spontaneous Supratentorial Lobar Intracerebral Haematomas).

Haley, Mark D / Gregson, Barbara A / Mould, W Andrew / Hanley, Daniel F / Mendelow, Alexander David

Stroke

2018 Volume 49, Issue 2, Page(s) 325–332

Abstract: Background and purpose: The ABC/2 method for calculating intracerebral hemorrhage (ICH) volume has been well validated. However, the formula, derived from the volume of an ellipse, assumes the shape of ICH is elliptical. We sought to compare the ... ...

Abstract	Background and purpose: The ABC/2 method for calculating intracerebral hemorrhage (ICH) volume has been well validated. However, the formula, derived from the volume of an ellipse, assumes the shape of ICH is elliptical. We sought to compare the agreement of the ABC/2 formula with other methods through retrospective analysis of a selection of the STICH II cohort (Early Surgery Versus Initial Conservative Treatment in Patients With Spontaneous Supratentorial Lobar Intracerebral Haematomas). Methods: From 390 patients, 739 scans were selected from the STICH II image archive based on the availability of a CT scan compatible with OsiriX DICOM viewer. ICH volumes were calculated by the reference standard semiautomatic segmentation in OsiriX software and compared with calculated arithmetic methods (ABC/2, ABC/2.4, ABC/3, and 2/3SC) volumes. Volumes were compared by difference plots for specific groups: randomization ICH (n=374), 3- to 7-day postsurgical ICH (n=206), antithrombotic-associated ICH (n=79), irregular-shape ICH (n=703) and irregular-density ICH (n=650). Density and shape were measured by the Barras ordinal shape and density groups (1-5). Results: The ABC/2.4 method had the closest agreement to the semiautomatic segmentation volume in all groups, except for the 3- to 7-day postsurgical ICH group where the ABC/3 method was superior. Conclusions: Although the ABC/2 formula for calculating elliptical ICH is well validated, it must be used with caution in ICH scans where the elliptical shape of ICH is a false assumption. We validated the adjustment of the ABC/2.4 method in randomization, antithrombotic-associated, heterogeneous-density, and irregular-shape ICH. Clinical trial registration: URL: http://www.isrctn.com/ISRCTN22153967. Unique identifier: ISRCTN22153967.
MeSH term(s)	Aged ; Aged, 80 and over ; Cerebral Hemorrhage/etiology ; Cerebral Hemorrhage/surgery ; Cohort Studies ; Conservative Treatment/methods ; Early Medical Intervention ; Female ; Hematoma/complications ; Humans ; Image Processing, Computer-Assisted ; Male ; Middle Aged ; Retrospective Studies ; Time Factors ; Tomography, X-Ray Computed/methods ; Treatment Outcome
Language	English
Publishing date	2018
Publishing country	United States
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	80381-9
ISSN	1524-4628 ; 0039-2499 ; 0749-7954
ISSN (online)	1524-4628
ISSN	0039-2499 ; 0749-7954
DOI	10.1161/STROKEAHA.117.016677
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Zs.A 448: Show issues

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Article ; Online: Haptoglobin is associated with increased early perihematoma edema progression in spontaneous intracranial hemorrhage.

Halstead, Michael R / Mould, W Andrew / Sheth, Kevin N / Rosand, Jonathan / Thompson, Richard / Levy, Andrew / Hanley, Daniel F / Goldstein, Joshua N / Nyquist, Paul

International journal of stroke : official journal of the International Stroke Society

2020 Volume 15, Issue 8, Page(s) 899–908

Abstract: Introduction: Perihematomal edema in intracranial hemorrhage is influenced by free hemoglobin clearance and inflammation. Serum Haptoglobin (Hp) binds free hemoglobin, affecting heme clearance and free radical production. Of the three Hp phenotypes, Hp ... ...

Abstract	Introduction: Perihematomal edema in intracranial hemorrhage is influenced by free hemoglobin clearance and inflammation. Serum Haptoglobin (Hp) binds free hemoglobin, affecting heme clearance and free radical production. Of the three Hp phenotypes, Hp 1-1 has the greatest effect on free hemoglobin clearance. Aim: To determine if individuals with Hp 1-1 phenotype have different rates of early perihematomal edema formation as compared to those with Hp 2-1 and Hp 2-2. Methods: We determined Hp phenotype, intracranial hemorrhage volume, and rate of early change in perihematomal volume in participants from three prospectively collected intracranial hemorrhage cohorts. The association of Hp phenotypes 1-1, 2-1, 2-2, with early change in perihematomal volume, while controlling for key clinical characteristics was analyzed using a multivariate model. Findings: One-hundred and sixty-six participants were included: 73 (44%) female, 41 ( 25%) African Americans, 34 (20%) diabetics, 133 (80%) with hypertension, and 75 (45%) active smokers. There were 15 subjects with Hp phenotype 1-1, 86 with 2-1, and 65 with 2-2. In fully adjusted analysis, Hp 1-1 had a significantly increased estimated mean rate of early change in perihematomal volume at 1.15 (95% confidence interval 0.58-1.71) as compared to all other Hp 2-1 or Hp 2-2 containing phenotypes (0.30, 95% confidence interval 0.06-0.54; 0.29 95% CI 0.02-0.56). Neither mortality nor discharge mRS differed between Hp phenotypes. Conclusion: Haptoglobin phenotype is associated with early change in perihematomal volume. Hp 1-1 phenotype had significantly increased mean rate of early change in perihematomal volume within the first 96 h, suggesting that haptoglobin phenotype may be a key player in understanding the multiphasic progression of perihematomal volume in spontaneous intracerebral hemorrhage. A larger prospective observational study is warranted.
MeSH term(s)	Brain Edema/etiology ; Cerebral Hemorrhage ; Edema ; Female ; Haptoglobins ; Humans ; Intracranial Hemorrhages/complications ; Male ; Stroke
Chemical Substances	Haptoglobins
Language	English
Publishing date	2020-04-07
Publishing country	United States
Document type	Journal Article ; Observational Study ; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't
ZDB-ID	2303728-3
ISSN	1747-4949 ; 1747-4930
ISSN (online)	1747-4949
ISSN	1747-4930
DOI	10.1177/1747493020912602
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Zs.A 6582: Show issues

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Article ; Online: Primary intraventricular hemorrhage outcomes in the CLEAR III trial.

Nelson, Sarah E / Mould, W Andrew / Gandhi, Dheeraj / Thompson, Richard E / Salter, Sarah / Dlugash, Rachel / Awad, Issam A / Hanley, Daniel F / Ziai, Wendy

International journal of stroke : official journal of the International Stroke Society

2020 Volume 15, Issue 8, Page(s) 872–880

Abstract: Background: Intraventricular hemorrhage occurs due to intracerebral hemorrhage with intraventricular extension or without apparent parenchymal involvement, known as primary intraventricular hemorrhage.: Aims: We evaluated the prognosis of primary ... ...

Abstract	Background: Intraventricular hemorrhage occurs due to intracerebral hemorrhage with intraventricular extension or without apparent parenchymal involvement, known as primary intraventricular hemorrhage. Aims: We evaluated the prognosis of primary intraventricular hemorrhage patients in the CLEAR III trial (Clot Lysis: Evaluating Accelerated Resolution of Intraventricular Hemorrhage). Methods: In patients with primary intraventricular hemorrhage versus those with secondary intraventricular hemorrhage, we compared intraventricular alteplase response and outcomes including modified Rankin Scale, Barthel Index, National Institutes of Health Stroke Scale (NIHSS), and extended Glasgow Outcome Scale (eGOS) at 30, 180, and 365 days. Outcomes were also compared in primary intraventricular hemorrhage patients who received intraventricular alteplase versus placebo (normal saline) and in matched primary and secondary intraventricular hemorrhage patients using inverse-probability-weighted regression adjustment. Results: Of 500 patients enrolled in CLEAR III, 46 (9.2%) had primary intraventricular hemorrhage. Combining both treatment groups, primary intraventricular hemorrhage patients had larger intraventricular hemorrhage volumes (median: 34.2 mL vs. 20.8 mL, Conclusions: In CLEAR III, primary intraventricular hemorrhage patients who survived achieved better long-term outcomes than surviving secondary intraventricular hemorrhage patients with similar mortality. Outcomes and safety were similar between primary intraventricular hemorrhage patients receiving alteplase and those receiving saline.
MeSH term(s)	Cerebral Hemorrhage/complications ; Cerebral Hemorrhage/drug therapy ; Fibrinolytic Agents/therapeutic use ; Humans ; Stroke/drug therapy ; Tissue Plasminogen Activator/therapeutic use ; Treatment Outcome
Chemical Substances	Fibrinolytic Agents ; Tissue Plasminogen Activator (EC 3.4.21.68)
Language	English
Publishing date	2020-02-19
Publishing country	United States
Document type	Journal Article ; Research Support, N.I.H., Extramural
ZDB-ID	2303728-3
ISSN	1747-4949 ; 1747-4930
ISSN (online)	1747-4949
ISSN	1747-4930
DOI	10.1177/1747493020908146
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Zs.A 6582: Show issues

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Article ; Online: Post-Trial Enhanced Deployment and Technical Performance with the MISTIE Procedure per Lessons Learned.

Mansour, Ali / Loggini, Andrea / El Ammar, Faten / Alvarado-Dyer, Ronald / Polster, Sean / Stadnik, Agnieszka / Das, Paramita / Warnke, Peter C / Yamini, Bakhtiar / Lazaridis, Christos / Kramer, Christopher / Mould, W Andrew / Hildreth, Meghan / Sharrock, Matthew / Hanley, Daniel F / Goldenberg, Fernando D / Awad, Issam A

Journal of stroke and cerebrovascular diseases : the official journal of National Stroke Association

2021 Volume 30, Issue 9, Page(s) 105996

Abstract: Objective: We hypothesize that procedure deployment rates and technical performance with minimally invasive surgery and thrombolysis for intracerebral hemorrhage (ICH) evacuation (MISTIE) can be enhanced in post-trial clinical practice, per Phase III ... ...

Abstract	Objective: We hypothesize that procedure deployment rates and technical performance with minimally invasive surgery and thrombolysis for intracerebral hemorrhage (ICH) evacuation (MISTIE) can be enhanced in post-trial clinical practice, per Phase III trial results and lessons learned. Materials and methods: We identified ICH patients and those who underwent MISTIE procedure between 2017-2021 at a single site, after completed enrollments in the Phase III trial. Deployment rates, complications and technical outcomes were compared to those observed in the trial. Initial and final hematoma volume were compared between site measurements using ABC/2, MISTIE trial reading center utilizing manual segmentation, and a novel Artificial Intelligence (AI) based volume assessment. Results: Nineteen of 286 patients were eligible for MISTIE. All 19 received the procedure (6.6% enrollment to screening rate 6.6% compared to 1.6% at our center in the trial; p=0.0018). Sixteen patients (84%) achieved evaculation target < 15 mL residual ICH or > 70% removal, compared to 59.7% in the trial surgical cohort (p=0.034). No poor catheter placement occurred and no surgical protocol deviations. Limitations of ICH volume assessments using the ABC/2 method were shown, while AI based methodology of ICH volume assessments had excellent correlation with manual segmentation by experienced reading centers. Conclusions: Greater procedure deployment and higher technical success rates can be achieved in post-trial clinical practice than in the MISTIE III trial. AI based measurements can be deployed to enhance clinician estimated ICH volume. Clinical outcome implications of this enhanced technical performance cannot be surmised, and will need assessment in future trials.
MeSH term(s)	Adult ; Aged ; Aged, 80 and over ; Artificial Intelligence ; Cerebral Hemorrhage/diagnostic imaging ; Cerebral Hemorrhage/therapy ; Clinical Trials, Phase III as Topic ; Databases, Factual ; Female ; Humans ; Male ; Middle Aged ; Neurosurgical Procedures/adverse effects ; Predictive Value of Tests ; Radiographic Image Interpretation, Computer-Assisted ; Retrospective Studies ; Thrombolytic Therapy/adverse effects ; Time Factors ; Tomography, X-Ray Computed ; Treatment Outcome
Language	English
Publishing date	2021-07-22
Publishing country	United States
Document type	Comparative Study ; Journal Article
ZDB-ID	1131675-5
ISSN	1532-8511 ; 1052-3057
ISSN (online)	1532-8511
ISSN	1052-3057
DOI	10.1016/j.jstrokecerebrovasdis.2021.105996
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Zs.A 3519: Show issues

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Article ; Online: Validated automatic brain extraction of head CT images.

Muschelli, John / Ullman, Natalie L / Mould, W Andrew / Vespa, Paul / Hanley, Daniel F / Crainiceanu, Ciprian M

NeuroImage

2015 Volume 114, Page(s) 379–385

Abstract: Background: X-ray computed tomography (CT) imaging of the brain is commonly used in diagnostic settings. Although CT scans are primarily used in clinical practice, they are increasingly used in research. A fundamental processing step in brain imaging ... ...

Abstract	Background: X-ray computed tomography (CT) imaging of the brain is commonly used in diagnostic settings. Although CT scans are primarily used in clinical practice, they are increasingly used in research. A fundamental processing step in brain imaging research is brain extraction - the process of separating the brain tissue from all other tissues. Methods for brain extraction have either been 1) validated but not fully automated, or 2) fully automated and informally proposed, but never formally validated. Aim: To systematically analyze and validate the performance of FSL's brain extraction tool (BET) on head CT images of patients with intracranial hemorrhage. This was done by comparing the manual gold standard with the results of several versions of automatic brain extraction and by estimating the reliability of automated segmentation of longitudinal scans. The effects of the choice of BET parameters and data smoothing is studied and reported. Methods: All images were thresholded using a 0-100 Hounsfield unit (HU) range. In one variant of the pipeline, data were smoothed using a 3-dimensional Gaussian kernel (σ=1mm(3)) and re-thresholded to 0-100HU; in the other, data were not smoothed. BET was applied using 1 of 3 fractional intensity (FI) thresholds: 0.01, 0.1, or 0.35 and any holes in the brain mask were filled. For validation against a manual segmentation, 36 images from patients with intracranial hemorrhage were selected from 19 different centers from the MISTIE (Minimally Invasive Surgery plus recombinant-tissue plasminogen activator for Intracerebral Evacuation) stroke trial. Intracranial masks of the brain were manually created by one expert CT reader. The resulting brain tissue masks were quantitatively compared to the manual segmentations using sensitivity, specificity, accuracy, and the Dice Similarity Index (DSI). Brain extraction performance across smoothing and FI thresholds was compared using the Wilcoxon signed-rank test. The intracranial volume (ICV) of each scan was estimated by multiplying the number of voxels in the brain mask by the dimensions of each voxel for that scan. From this, we calculated the ICV ratio comparing manual and automated segmentation: ICVautomated/ICVmanual. To estimate the performance in a large number of scans, brain masks were generated from the 6 BET pipelines for 1095 longitudinal scans from 129 patients. Failure rates were estimated from visual inspection. ICV of each scan was estimated and an intraclass correlation (ICC) was estimated using a one-way ANOVA. Results: Smoothing images improves brain extraction results using BET for all measures except specificity (all p<0.01, uncorrected), irrespective of the FI threshold. Using an FI of 0.01 or 0.1 performed better than 0.35. Thus, all reported results refer only to smoothed data using an FI of 0.01 or 0.1. Using an FI of 0.01 had a higher median sensitivity (0.9901) than an FI of 0.1 (0.9884, median difference: 0.0014, p<0.001), accuracy (0.9971 vs. 0.9971; median difference: 0.0001, p<0.001), and DSI (0.9895 vs. 0.9894; median difference: 0.0004, p<0.001) and lower specificity (0.9981 vs. 0.9982; median difference: -0.0001, p<0.001). These measures are all very high indicating that a range of FI values may produce visually indistinguishable brain extractions. Using smoothed data and an FI of 0.01, the mean (SD) ICV ratio was 1.002 (0.008); the mean being close to 1 indicates the ICV estimates are similar for automated and manual segmentation. In the 1095 longitudinal scans, this pipeline had a low failure rate (5.2%) and the ICC estimate was high (0.929, 95% CI: 0.91, 0.945) for successfully extracted brains. Conclusion: BET performs well at brain extraction on thresholded, 1mm(3) smoothed CT images with an FI of 0.01 or 0.1. Smoothing before applying BET is an important step not previously discussed in the literature. Analysis code is provided.
MeSH term(s)	Brain/pathology ; Female ; Head ; Humans ; Image Processing, Computer-Assisted/methods ; Intracranial Hemorrhages/pathology ; Male ; Middle Aged ; Pattern Recognition, Automated/methods ; Reproducibility of Results ; Tomography, X-Ray Computed/methods
Language	English
Publishing date	2015-07-01
Publishing country	United States
Document type	Journal Article ; Research Support, N.I.H., Extramural
ZDB-ID	1147767-2
ISSN	1095-9572 ; 1053-8119
ISSN (online)	1095-9572
ISSN	1053-8119
DOI	10.1016/j.neuroimage.2015.03.074
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Zs.A 3664: Show issues			Location: Je nach Verfügbarkeit (siehe Angabe bei Bestand) bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular Jg. 1995 - 2021: Lesesall (2.OG) ab Jg. 2022: Lesesaal (EG)
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Article ; Online: Design and Protocol of the Renal Anhydramnios Fetal Therapy (RAFT) Trial.

Atkinson, Meredith A / Jelin, Eric B / Baschat, Ahmet / Blumenfeld, Yair J / Chmait, Ramen H / O'Hare, Elizabeth / Moldenhauer, Julie S / Zaretsky, Michael V / Miller, Russell S / Ruano, Rodrigo / Gonzalez, Juan M / Johnson, Anthony / Mould, W Andrew / Davis, Jonathan M / Hanley, Daniel F / Keiser, Amaris M / Rosner, Mara / Miller, Jena L

Clinical therapeutics

2022 Volume 44, Issue 8, Page(s) 1161–1171

Abstract: Purpose: Anhydramnios secondary to anuria before 22 weeks of gestational age and congenital bilateral renal agenesis before 26 weeks of gestational age are collectively referred to as early-pregnancy renal anhydramnios. Early-pregnancy renal ... ...

Abstract	Purpose: Anhydramnios secondary to anuria before 22 weeks of gestational age and congenital bilateral renal agenesis before 26 weeks of gestational age are collectively referred to as early-pregnancy renal anhydramnios. Early-pregnancy renal anhydramnios occurs in at least 1 in 2000 pregnancies and is considered universally fatal when left untreated because of severe pulmonary hypoplasia precluding ex utero survival The Renal Anhydramnios Fetal Therapy (RAFT) trial is a nonrandomized, nonblinded, multicenter clinical trial designed to assess the efficacy, safety, and feasibility of amnioinfusions for patients with pregnancies complicated by early-pregnancy renal anhydramnios. The primary objective of this study is to determine the proportion of neonates surviving to successful dialysis, defined as use of a dialysis catheter for ≥14 days. Methods: A consortium of 9 North American Fetal Therapy Network (NAFTNet) centers was formed, and the RAFT protocol was refined in collaboration with the NAFTNet Scientific Committee. Enrollment in the trial began in April 2020. Participants may elect to receive amnioinfusions or to join the nonintervention observational expectant management group. Eligible pregnant women must be at least 18 years of age with a fetal diagnosis of isolated early-pregnancy renal anhydramnios. Findings: In addition to the primary study objective stated above, secondary objectives include (1) to assess maternal safety and feasibility of the serial amnioinfusion intervention (2) to perform an exploratory study of the natural history of untreated early pregnancy renal anhydramnios (3) to examine correlations between prenatal imaging and lung specific factors in amniotic fluid as predictive of the efficacy of serial percutaneous amnioinfusions and (4) to determine short- and long-term outcomes and quality of life in surviving neonates and families enrolled in RAFT IMPLICATIONS: The RAFT trial is the first clinical trial to investigate the efficacy, safety, and feasibility of amnioinfusions to treat the survival-limiting pulmonary hypoplasia associated with anhydramnios. Although the intervention offers an opportunity to treat a condition known to be almost universally fatal in affected neonates, the potential burdens associated with end-stage kidney disease from birth must be acknowledged. Clinicaltrials: gov identifier: NCT03101891.
MeSH term(s)	Amniotic Fluid ; Female ; Fetal Therapies ; Gestational Age ; Humans ; Infant, Newborn ; Multicenter Studies as Topic ; Oligohydramnios/therapy ; Pregnancy ; Quality of Life
Language	English
Publishing date	2022-07-30
Publishing country	United States
Document type	Clinical Trial ; Journal Article ; Research Support, N.I.H., Extramural
ZDB-ID	603113-4
ISSN	1879-114X ; 0149-2918
ISSN (online)	1879-114X
ISSN	0149-2918
DOI	10.1016/j.clinthera.2022.07.001
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Article ; Online: Decentralized clinical trials in the trial innovation network: Value, strategies, and lessons learned.

Hanley, Daniel F / Bernard, Gordon R / Wilkins, Consuelo H / Selker, Harry P / Dwyer, Jamie P / Dean, J Michael / Benjamin, Daniel Kelly / Dunsmore, Sarah E / Waddy, Salina P / Wiley, Kenneth L / Palm, Marisha E / Mould, W Andrew / Ford, Daniel F / Burr, Jeri S / Huvane, Jacqueline / Lane, Karen / Poole, Lori / Edwards, Terri L / Kennedy, Nan /

Boone, Leslie R / Bell, Jasmine / Serdoz, Emily / Byrne, Loretta M / Harris, Paul A

Journal of clinical and translational science

2023 Volume 7, Issue 1, Page(s) e170

Abstract: New technologies and disruptions related to Coronavirus disease-2019 have led to expansion of decentralized approaches to clinical trials. Remote tools and methods hold promise for increasing trial efficiency and reducing burdens and barriers by ... ...

Abstract	New technologies and disruptions related to Coronavirus disease-2019 have led to expansion of decentralized approaches to clinical trials. Remote tools and methods hold promise for increasing trial efficiency and reducing burdens and barriers by facilitating participation outside of traditional clinical settings and taking studies directly to participants. The Trial Innovation Network, established in 2016 by the National Center for Advancing Clinical and Translational Science to address critical roadblocks in clinical research and accelerate the translational research process, has consulted on over 400 research study proposals to date. Its recommendations for decentralized approaches have included eConsent, participant-informed study design, remote intervention, study task reminders, social media recruitment, and return of results for participants. Some clinical trial elements have worked well when decentralized, while others, including remote recruitment and patient monitoring, need further refinement and assessment to determine their value. Partially decentralized, or "hybrid" trials, offer a first step to optimizing remote methods. Decentralized processes demonstrate potential to improve urban-rural diversity, but their impact on inclusion of racially and ethnically marginalized populations requires further study. To optimize inclusive participation in decentralized clinical trials, efforts must be made to build trust among marginalized communities, and to ensure access to remote technology.
Language	English
Publishing date	2023-07-25
Publishing country	England
Document type	Journal Article
ISSN	2059-8661
ISSN (online)	2059-8661
DOI	10.1017/cts.2023.597
Database	MEDical Literature Analysis and Retrieval System OnLINE

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