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Article ; Online: Clinical Translation of the National Institutes of Health's Investments in Nanodrug Products and Devices.

Henderson, Lori A / Shankar, Lalitha K

The AAPS journal

2017 Volume 19, Issue 2, Page(s) 343–359

Abstract: The National Institutes of Health (NIH), a part of the U.S. Department of Health and Human Services, is the primary Federal agency for conducting and supporting biomedical research. The NIH's mission is to seek fundamental knowledge about the nature and ... ...

Abstract	The National Institutes of Health (NIH), a part of the U.S. Department of Health and Human Services, is the primary Federal agency for conducting and supporting biomedical research. The NIH's mission is to seek fundamental knowledge about the nature and behavior of living systems and to apply that knowledge to enhance health, lengthen life, and reduce illness and disability. In support of this mission, NIH has invested about $4.4 billion since 2001 in nanotechnology (NT) research. This investment is leading to fundamental changes in understanding biological processes in health and disease, as well as enabling novel diagnostics and interventions for treating disease. NIH scientists are developing molecular agents and methods for earlier and more accurate diagnosis and therapies aimed directly and selectively at diseased cells, and are exploring root causes of common and rare diseases at the nanoscale. Work is also underway to move these research tools and devices into clinical practice. This particular investigative review examines the NIH NT portfolio linked to clinical trials from FY2008 to FY2015 to assess the progress of clinical translation. Among the subset of trials identified, 70% target drug or combination drug-device products used in treating cancer, AIDS, and other various diseases. The review also provides insight into trends observed from studying the clinical research portfolio.
MeSH term(s)	Biomedical Research/economics ; Biomedical Research/organization & administration ; Clinical Trials as Topic/economics ; Humans ; Nanotechnology ; National Institutes of Health (U.S.)/economics ; National Institutes of Health (U.S.)/organization & administration ; Research Support as Topic ; Translational Medical Research/economics ; Translational Medical Research/organization & administration ; United States
Language	English
Publishing date	2017
Publishing country	United States
Document type	Journal Article ; Review
ISSN	1550-7416
ISSN (online)	1550-7416
DOI	10.1208/s12248-016-9995-x
Database	MEDical Literature Analysis and Retrieval System OnLINE

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Article ; Online: The clinical evaluation of novel imaging methods for cancer management.

Shankar, Lalitha K

Nature reviews. Clinical oncology

2012 Volume 9, Issue 12, Page(s) 738–744

Abstract: The National Cancer Institute (NCI) has a long-standing interest in evaluating and using the known advantages of molecular and functional imaging, as well as assessing the potential of novel imaging agents and modalities, to improve clinical cancer ... ...

Abstract	The National Cancer Institute (NCI) has a long-standing interest in evaluating and using the known advantages of molecular and functional imaging, as well as assessing the potential of novel imaging agents and modalities, to improve clinical cancer research and cancer care. In this Perspectives article, I discuss the strategies and resources being used by the NCI to foster and enhance these evaluations. Although resource and logistical challenges abound in successfully mounting these trials, many examples exist of real and potential solutions to improve the clinical evaluation process for imaging agents and modalities in the USA and in international collaborations.
MeSH term(s)	Animals ; Diagnostic Imaging/methods ; Disease Management ; Humans ; National Cancer Institute (U.S.) ; Neoplasms/diagnosis ; Neoplasms/therapy ; United States
Language	English
Publishing date	2012-11-13
Publishing country	England
Document type	Review
ZDB-ID	2491410-1
ISSN	1759-4782 ; 1759-4774
ISSN (online)	1759-4782
ISSN	1759-4774
DOI	10.1038/nrclinonc.2012.186
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Article ; Online: A Statistical Model of Expansive Growth in Plant and Fungal Cells: The Case of Phycomyces.

Lalitha Sridhar, Shankar / Ortega, Joseph K E / Vernerey, Franck J

Biophysical journal

2018 Volume 115, Issue 12, Page(s) 2428–2442

Abstract: Expansive growth is a process by which walled cells of plants, algae, and fungi use turgor pressure to mediate irreversible wall deformation and regulate their shape and volume. The molecular structure of the primary cell wall must therefore perform ... ...

Abstract	Expansive growth is a process by which walled cells of plants, algae, and fungi use turgor pressure to mediate irreversible wall deformation and regulate their shape and volume. The molecular structure of the primary cell wall must therefore perform multiple functions simultaneously, including providing structural support by combining elastic and irreversible deformation and facilitating the deposition of new material during growth. This is accomplished by a network of microfibrils and tethers composed of complex polysaccharides and proteins that can dynamically mediate the network topology via periodic detachment and reattachment events. Lockhart and Ortega have provided crucial macroscopic understanding of the expansive growth process through global biophysical models, but these models lack the connection to molecular processes that trigger network rearrangements in the wall. Interestingly, the helical growth of the fungal sporangiophores of Phycomyces blakesleeanus is attributed to a limited region (called the growth zone) where microfibrils are deposited, followed by reorientation and slip. Based on past evidence of dominant shear strain between microfibrils (slippage), we propose a mechanistic model of a network of sliding fibrils connected by tethers. A statistical approach is introduced to describe the population behavior of tethers that have elastic properties and the ability to break and reform in time. These properties are responsible for global cell wall mechanics such as creep and stress relaxation. Model predictions are compared with experiments from literature on stress relaxation and turgor pressure step up for the growing cells of P. blakesleeanus, which are later extended to incised pea (Pisum sativus L.) and the algae Chara corallina using the unique dimensionless number Π
MeSH term(s)	Cell Wall/metabolism ; Chara/cytology ; Models, Biological ; Pisum sativum/cytology ; Phycomyces/cytology
Language	English
Publishing date	2018-11-17
Publishing country	United States
Document type	Journal Article ; Research Support, U.S. Gov't, Non-P.H.S.
ZDB-ID	218078-9
ISSN	1542-0086 ; 0006-3495
ISSN (online)	1542-0086
ISSN	0006-3495
DOI	10.1016/j.bpj.2018.11.014
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Article ; Online: Helical growth during the phototropic response, avoidance response, and in stiff mutants of Phycomyces blakesleeanus.

Ortega, Joseph K E / Mohan, Revathi P / Munoz, Cindy M / Sridhar, Shankar Lalitha / Vernerey, Franck J

Scientific reports

2021 Volume 11, Issue 1, Page(s) 3653

Abstract: The sporangiophores of Phycomyces blakesleeanus have been used as a model system to study sensory transduction, helical growth, and to establish global biophysical equations for expansive growth of walled cells. More recently, local statistical ... ...

Abstract	The sporangiophores of Phycomyces blakesleeanus have been used as a model system to study sensory transduction, helical growth, and to establish global biophysical equations for expansive growth of walled cells. More recently, local statistical biophysical models of the cell wall are being constructed to better understand the molecular underpinnings of helical growth and its behavior during the many growth responses of the sporangiophores to sensory stimuli. Previous experimental and theoretical findings guide the development of these local models. Future development requires an investigation of explicit and implicit assumptions made in the prior research. Here, experiments are conducted to test three assumptions made in prior research, that (a) elongation rate, (b) rotation rate, and (c) helical growth steepness, R, of the sporangiophore remain constant during the phototropic response (bending toward unilateral light) and the avoidance response (bending away from solid barriers). The experimental results reveal that all three assumptions are incorrect for the phototropic response and probably incorrect for the avoidance response but the results are less conclusive. Generally, the experimental results indicate that the elongation and rotation rates increase during these responses, as does R, indicating that the helical growth steepness become flatter. The implications of these findings on prior research, the "fibril reorientation and slippage" hypothesis, global biophysical equations, and local statistical biophysical models are discussed.
MeSH term(s)	Biological Phenomena ; Biophysics/trends ; Cell Wall/physiology ; Cell Wall/radiation effects ; Gravitropism/physiology ; Gravitropism/radiation effects ; Light ; Models, Biological ; Phototropism/physiology ; Phototropism/radiation effects ; Phycomyces/growth & development ; Phycomyces/radiation effects
Language	English
Publishing date	2021-02-11
Publishing country	England
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	2615211-3
ISSN	2045-2322 ; 2045-2322
ISSN (online)	2045-2322
ISSN	2045-2322
DOI	10.1038/s41598-021-83254-5
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Article ; Online: Beyond Correlations, Sensitivities, and Specificities: Case Examples of the Evaluation of Advanced Imaging in Oncology Clinical Trials and Cancer Treatment.

Lin, Frank I / Huang, Erich P / Shankar, Lalitha K

Academic radiology

2017 Volume 24, Issue 8, Page(s) 1027–1035

Abstract: Although advanced imaging is an important component of oncology clinical trials, there has not been a lot of success in advancing its use from a research perspective. One likely reason is the lack of consensus on the methodology used to study advanced ... ...

Abstract	Although advanced imaging is an important component of oncology clinical trials, there has not been a lot of success in advancing its use from a research perspective. One likely reason is the lack of consensus on the methodology used to study advanced imaging in trials, which results in a disconcerted research effort and produces data that are difficult to collate for use in validating the imaging components being studied. Imaging is used in cancer clinical trials for various indications, and the study design needed to evaluate the imaging in a particular indication will vary. Through case examples, this paper will discuss how advanced imaging is currently being investigated in oncology clinical trials, categorized by the potential clinical indication for the imaging tool and offer suggestions on how development should proceed to further evaluate imaging in the given indication. Available National Cancer Institute resources that can assist in this process will also be discussed.
MeSH term(s)	Biomarkers, Tumor ; Clinical Trials as Topic ; Diagnostic Imaging/methods ; Endpoint Determination ; Humans ; Neoplasm Staging ; Neoplasms/diagnostic imaging ; Neoplasms/pathology ; Neoplasms/therapy ; Prognosis ; Research Design
Chemical Substances	Biomarkers, Tumor
Language	English
Publishing date	2017-04-11
Publishing country	United States
Document type	Journal Article ; Review
ZDB-ID	1355509-1
ISSN	1878-4046 ; 1076-6332
ISSN (online)	1878-4046
ISSN	1076-6332
DOI	10.1016/j.acra.2016.11.024
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Article ; Online: Beyond Correlations, Sensitivities, and Specificities: A Roadmap for Demonstrating Utility of Advanced Imaging in Oncology Treatment and Clinical Trial Design.

Huang, Erich P / Lin, Frank I / Shankar, Lalitha K

Academic radiology

2017 Volume 24, Issue 8, Page(s) 1036–1049

Abstract: Despite the widespread belief that advanced imaging should be very helpful in guiding oncology treatment decision and improving efficiency and success rates in treatment clinical trials, its acceptance has been slow. Part of this is likely attributable ... ...

Abstract	Despite the widespread belief that advanced imaging should be very helpful in guiding oncology treatment decision and improving efficiency and success rates in treatment clinical trials, its acceptance has been slow. Part of this is likely attributable to gaps in study design and statistical methodology for these imaging studies. Also, results supporting the performance of the imaging in these roles have largely been insufficient to justify their use within the design of a clinical trial or in treatment decision making. Statistically significant correlations between the imaging results and clinical outcomes are often incorrectly taken as evidence of adequate performance. Assessments of whether the imaging can outperform standard techniques or meaningfully supplement them are also frequently neglected. This paper provides guidance on study designs and statistical analyses for evaluating the performance of advanced imaging in the various roles in treatment decision guidance and clinical trial conduct. Relevant methodology from the imaging literature is reviewed; gaps in the literature are addressed using related concepts from the more extensive genomic and in vitro biomarker literature.
MeSH term(s)	Biomarkers, Tumor ; Clinical Decision-Making ; Clinical Trials as Topic ; Data Interpretation, Statistical ; Diagnostic Imaging/methods ; Humans ; Neoplasm Staging ; Neoplasms/diagnostic imaging ; Neoplasms/pathology ; Neoplasms/therapy ; Prognosis ; Research Design ; Treatment Outcome
Chemical Substances	Biomarkers, Tumor
Language	English
Publishing date	2017-04-26
Publishing country	United States
Document type	Journal Article ; Review
ZDB-ID	1355509-1
ISSN	1878-4046 ; 1076-6332
ISSN (online)	1878-4046
ISSN	1076-6332
DOI	10.1016/j.acra.2017.03.002
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Article: Standardization of PET Imaging in Clinical Trials.

Shankar, Lalitha K

PET clinics

2008 Volume 3, Issue 1, Page(s) 1–4

Abstract: A biomarker is a characteristic that is objectively measured and evaluated as an indicator of normal biologic processes, pathogenic processes, or pharmacologic responses to a therapeutic intervention. In vitro biomarkers include histopathologic and ... ...

Abstract	A biomarker is a characteristic that is objectively measured and evaluated as an indicator of normal biologic processes, pathogenic processes, or pharmacologic responses to a therapeutic intervention. In vitro biomarkers include histopathologic and serologic correlates and the newer genomic and proteomic assays. In vivo biomarkers include evaluation of disease extent with CT and MR imaging and disease characterization using molecular and functional imaging with single-photon emission CT, PET, and optical agents. This article reviews the various roles a biomarker can play and the path of evaluation and development of these assays. The specifics of development of PET biomarkers and the role that standardization plays are highlighted.
Language	English
Publishing date	2008-01
Publishing country	United States
Document type	Journal Article ; Review
ZDB-ID	2764575-7
ISSN	1879-9809 ; 1556-8598
ISSN (online)	1879-9809
ISSN	1556-8598
DOI	10.1016/j.cpet.2008.10.006
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Article ; Online: Helical growth during the phototropic response, avoidance response, and in stiff mutants of Phycomyces blakesleeanus

Joseph K. E. Ortega / Revathi P. Mohan / Cindy M. Munoz / Shankar Lalitha Sridhar / Franck J. Vernerey

Scientific Reports, Vol 11, Iss 1, Pp 1-

2021 Volume 18

Abstract: Abstract The sporangiophores of Phycomyces blakesleeanus have been used as a model system to study sensory transduction, helical growth, and to establish global biophysical equations for expansive growth of walled cells. More recently, local statistical ... ...

Abstract	Abstract The sporangiophores of Phycomyces blakesleeanus have been used as a model system to study sensory transduction, helical growth, and to establish global biophysical equations for expansive growth of walled cells. More recently, local statistical biophysical models of the cell wall are being constructed to better understand the molecular underpinnings of helical growth and its behavior during the many growth responses of the sporangiophores to sensory stimuli. Previous experimental and theoretical findings guide the development of these local models. Future development requires an investigation of explicit and implicit assumptions made in the prior research. Here, experiments are conducted to test three assumptions made in prior research, that (a) elongation rate, (b) rotation rate, and (c) helical growth steepness, R, of the sporangiophore remain constant during the phototropic response (bending toward unilateral light) and the avoidance response (bending away from solid barriers). The experimental results reveal that all three assumptions are incorrect for the phototropic response and probably incorrect for the avoidance response but the results are less conclusive. Generally, the experimental results indicate that the elongation and rotation rates increase during these responses, as does R, indicating that the helical growth steepness become flatter. The implications of these findings on prior research, the “fibril reorientation and slippage” hypothesis, global biophysical equations, and local statistical biophysical models are discussed.
Keywords	Medicine ; R ; Science ; Q
Subject code	612
Language	English
Publishing date	2021-02-01T00:00:00Z
Publisher	Nature Portfolio
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Criteria for the translation of radiomics into clinically useful tests.

Huang, Erich P / O'Connor, James P B / McShane, Lisa M / Giger, Maryellen L / Lambin, Philippe / Kinahan, Paul E / Siegel, Eliot L / Shankar, Lalitha K

Nature reviews. Clinical oncology

2022 Volume 20, Issue 2, Page(s) 69–82

Abstract: Computer-extracted tumour characteristics have been incorporated into medical imaging computer-aided diagnosis (CAD) algorithms for decades. With the advent of radiomics, an extension of CAD involving high-throughput computer-extracted quantitative ... ...

Abstract	Computer-extracted tumour characteristics have been incorporated into medical imaging computer-aided diagnosis (CAD) algorithms for decades. With the advent of radiomics, an extension of CAD involving high-throughput computer-extracted quantitative characterization of healthy or pathological structures and processes as captured by medical imaging, interest in such computer-extracted measurements has increased substantially. However, despite the thousands of radiomic studies, the number of settings in which radiomics has been successfully translated into a clinically useful tool or has obtained FDA clearance is comparatively small. This relative dearth might be attributable to factors such as the varying imaging and radiomic feature extraction protocols used from study to study, the numerous potential pitfalls in the analysis of radiomic data, and the lack of studies showing that acting upon a radiomic-based tool leads to a favourable benefit-risk balance for the patient. Several guidelines on specific aspects of radiomic data acquisition and analysis are already available, although a similar roadmap for the overall process of translating radiomics into tools that can be used in clinical care is needed. Herein, we provide 16 criteria for the effective execution of this process in the hopes that they will guide the development of more clinically useful radiomic tests in the future.
Language	English
Publishing date	2022-11-28
Publishing country	England
Document type	Journal Article ; Review
ZDB-ID	2491410-1
ISSN	1759-4782 ; 1759-4774
ISSN (online)	1759-4782
ISSN	1759-4774
DOI	10.1038/s41571-022-00707-0
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Article ; Online: Meta-Analysis of the Test-Retest Repeatability of [18F]-Fluorodeoxyglucose Standardized Uptake Values: Implications for Assessment of Tumor Response.

Shankar, Lalitha K / Huang, Erich / Litiere, Saskia / Hoekstra, Otto S / Schwartz, Larry / Collette, Sandra / Boellaard, Ronald / Bogaerts, Jan / Seymour, Lesley / deVries, Elisabeth G E

Clinical cancer research : an official journal of the American Association for Cancer Research

2022 Volume 29, Issue 1, Page(s) 143–153

Abstract: Purpose: Currently, guidelines for PET with 18F-fluorodeoxyglucose (FDG-PET) interpretation for assessment of therapy response in oncology primarily involve visual evaluation of FDG-PET/CT scans. However, quantitative measurements of the metabolic ... ...

Abstract	Purpose: Currently, guidelines for PET with 18F-fluorodeoxyglucose (FDG-PET) interpretation for assessment of therapy response in oncology primarily involve visual evaluation of FDG-PET/CT scans. However, quantitative measurements of the metabolic activity in tumors may be even more useful in evaluating response to treatment. Guidelines based on such measurements, including the European Organization for Research and Treatment of Cancer Criteria and PET Response Criteria in Solid Tumors, have been proposed. However, more rigorous analysis of response criteria based on FDG-PET measurements is needed to adopt regular use in practice. Experimental design: Well-defined boundaries of repeatability and reproducibility of quantitative measurements to discriminate noise from true signal changes are a needed initial step. An extension of the meta-analysis from de Langen and colleagues (2012) of the test-retest repeatability of quantitative FDG-PET measurements, including mean, maximum, and peak standardized uptake values (SUVmax, SUVmean, and SUVpeak, respectively), was performed. Data from 11 studies in the literature were used to estimate the relationship between the variance in test-retest measurements with uptake level and various study-level, patient-level, and lesion-level characteristics. Results: Test-retest repeatability of percentage fluctuations for all three types of SUV measurement (max, mean, and peak) improved with higher FDG uptake levels. Repeatability in all three SUV measurements varied for different lesion locations. Worse repeatability in SUVmean was also associated with higher tumor volumes. Conclusions: On the basis of these results, recommendations regarding SUV measurements for assessing minimal detectable changes based on repeatability and reproducibility are proposed. These should be applied to differentiate between response categories for a future set of FDG-PET-based criteria that assess clinically significant changes in tumor response.
MeSH term(s)	Humans ; Fluorodeoxyglucose F18/metabolism ; Positron Emission Tomography Computed Tomography/methods ; Reproducibility of Results ; Neoplasms/diagnostic imaging ; Neoplasms/metabolism ; Positron-Emission Tomography/methods ; Radiopharmaceuticals
Chemical Substances	Fluorodeoxyglucose F18 (0Z5B2CJX4D) ; Radiopharmaceuticals
Language	English
Publishing date	2022-10-27
Publishing country	United States
Document type	Meta-Analysis ; Journal Article
ZDB-ID	1225457-5
ISSN	1557-3265 ; 1078-0432
ISSN (online)	1557-3265
ISSN	1078-0432
DOI	10.1158/1078-0432.CCR-21-3143
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