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Article ; Online: SNMMI Clinical Trials Network Research Series for Technologists: Clinical Research Primer- Use of Imaging Agents in Therapeutic Drug Development and Approval.

Jeffers, Charlotte D / Lawhn-Heath, Courtney / Butterfield, Regan I / Hoffman, John M / Scott, Peter J H

2022

Abstract: The process of bringing a new drug to market is complex and has recently necessitated a new drug discovery paradigm for the pharmaceutical industry that is both more efficient and more economical. Key to this has been the increasing use of nuclear ... ...

Abstract	The process of bringing a new drug to market is complex and has recently necessitated a new drug discovery paradigm for the pharmaceutical industry that is both more efficient and more economical. Key to this has been the increasing use of nuclear medicine and molecular imaging to support drug discovery efforts by answering critical questions on the pathway for development and approval of a new therapeutic drug. Some of these questions include: (i) Does the new drug reach its intended target in the body at sufficient levels to effectively treat or diagnose disease without unacceptable toxicity? (ii) How is the drug absorbed, metabolized, and excreted? (iii) What is the effective dose in humans? To conduct the appropriate imaging studies to answer such questions, pharmaceutical companies are increasingly partnering with molecular imaging departments. Nuclear medicine technologists are critical to this process as they perform scans to collect the qualitative and quantitative imaging data used to measure study endpoints. This article describes preclinical and clinical research trials and provides an overview of the different ways that radiopharmaceuticals are used to answer critical questions during therapeutic drug development.
Language	English
Publishing date	2022-06-14
Publishing country	United States
Document type	Journal Article
ZDB-ID	189163-7
ISSN	1535-5675 ; 0091-4916
ISSN (online)	1535-5675
ISSN	0091-4916
DOI	10.2967/jnmt.122.264372
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Article ; Online: Prospective Pilot Study of

Covington, Matthew F / Hoffman, John M / Morton, Kathryn A / Buckway, Brandon / Boucher, Kenneth M / Rosenthal, Regina E / Porretta, Jane M / Brownson, Kirstyn E / Matsen, Cindy B / Vaklavas, Christos / Ward, John H / Wei, Mei / Buys, Saundra S / Chittoria, Namita / Yakish, Ellen D / Archibald, Zane G / Burrell, Lance D / Butterfield, Regan I / Yap, Jeffrey T

AJR. American journal of roentgenology

2023 Volume 221, Issue 2, Page(s) 228–239

Abstract: BACKGROUND. ...

Abstract	BACKGROUND.
MeSH term(s)	Humans ; Middle Aged ; Aged ; Female ; Positron Emission Tomography Computed Tomography/methods ; Carcinoma, Lobular/diagnostic imaging ; Carcinoma, Lobular/pathology ; Pilot Projects ; Fluorodeoxyglucose F18 ; Prospective Studies ; Breast Neoplasms/diagnostic imaging ; Breast Neoplasms/pathology ; Positron-Emission Tomography/methods ; Estradiol
Chemical Substances	Fluorodeoxyglucose F18 (0Z5B2CJX4D) ; Estradiol (4TI98Z838E)
Language	English
Publishing date	2023-03-15
Publishing country	United States
Document type	Journal Article
ZDB-ID	82076-3
ISSN	1546-3141 ; 0361-803X ; 0092-5381
ISSN (online)	1546-3141
ISSN	0361-803X ; 0092-5381
DOI	10.2214/AJR.22.28809
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Article ; Online: FDG and FLT-PET for Early measurement of response to 37.5 mg daily sunitinib therapy in metastatic renal cell carcinoma.

Horn, Kevin P / Yap, Jeffrey T / Agarwal, Neeraj / Morton, Kathryn A / Kadrmas, Dan J / Beardmore, Britney / Butterfield, Regan I / Boucher, Kenneth / Hoffman, John M

Cancer imaging : the official publication of the International Cancer Imaging Society

2015 Volume 15, Page(s) 15

Abstract: Background: Metastatic renal cell carcinoma has a poor prognosis and an intrinsic resistance to standard treatment. Sunitinib is an oral receptor tyrosine kinase inhibitor that has been used as a first-line targeted therapy in metastatic renal cell ... ...

Abstract	Background: Metastatic renal cell carcinoma has a poor prognosis and an intrinsic resistance to standard treatment. Sunitinib is an oral receptor tyrosine kinase inhibitor that has been used as a first-line targeted therapy in metastatic renal cell carcinoma. While computed tomography (CT) is currently the gold standard for response assessment in oncological trials, numerous studies have shown that positron emission tomography (PET) imaging can provide information predictive of tumor response to treatment earlier than the typical interval for standard of care follow-up CT imaging. In this exploratory study we sought to characterize early tumor response in patients with metastatic renal cell carcinoma treated with continuous daily 37.5 mg sunitinib therapy. Methods: Twenty patients underwent dynamic acquisition positron emission tomography (PET) imaging using (18) F-fluorodeoxyglucose (FDG) and (18) F-fluorothymidine (FLT) at baseline and early in treatment (after 1, 2, 3 or 4 weeks) with 37.5 mg continuous daily dosing of sunitinib. Semi-quantitative analyses were performed to characterize the tumor metabolic (FDG) and proliferative (FLT) responses to treatment. Results: Proliferative responses were observed in 9/19 patients and occurred in 2 patients at one week (the earliest interval evaluated) after the initiation of therapy. A metabolic response was observed in 5/19 patients, however this was not observed until after two weeks of therapy were completed. Metabolic progression was observed in 2/19 patients and proliferative progression was observed in 1/19 patients. Baseline FDG-PET tumor maximum standardized uptake values correlated inversely with overall survival (p = 0.0036). Conversely, baseline (18) F-fluorothymidine PET imaging did not have prognostic value (p = 0.56) but showed a greater early response rate at 1-2 weeks after initiating therapy. Conclusions: While preliminary in nature, these results show an immediate and sustained proliferative response followed by a delayed metabolic response beginning after two weeks in metastatic renal cell carcinoma treated with a continuous daily dose of 37.5 mg sunitinib. The results provide evidence of tumor response to lower-dose sunitinib while also supporting the inclusion of PET imaging as a tool for early assessment in oncological clinical trials. Trial registration: ID: NCT00694096.
MeSH term(s)	Aged ; Aged, 80 and over ; Angiogenesis Inhibitors/therapeutic use ; Antineoplastic Agents/administration & dosage ; Carcinoma, Renal Cell/drug therapy ; Carcinoma, Renal Cell/metabolism ; Carcinoma, Renal Cell/mortality ; Carcinoma, Renal Cell/secondary ; Dideoxynucleosides ; Female ; Fluorine Radioisotopes ; Fluorodeoxyglucose F18 ; Humans ; Image Processing, Computer-Assisted ; Indoles/administration & dosage ; Kidney Neoplasms/drug therapy ; Kidney Neoplasms/metabolism ; Kidney Neoplasms/mortality ; Kidney Neoplasms/secondary ; Male ; Middle Aged ; Positron-Emission Tomography ; Pyrroles/administration & dosage ; Radiopharmaceuticals ; Treatment Outcome
Chemical Substances	Angiogenesis Inhibitors ; Antineoplastic Agents ; Dideoxynucleosides ; Fluorine Radioisotopes ; Indoles ; Pyrroles ; Radiopharmaceuticals ; Fluorodeoxyglucose F18 (0Z5B2CJX4D) ; alovudine (PG53R0DWDQ) ; sunitinib (V99T50803M)
Language	English
Publishing date	2015-09-03
Publishing country	England
Document type	Journal Article ; Randomized Controlled Trial ; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't
ISSN	1470-7330
ISSN (online)	1470-7330
DOI	10.1186/s40644-015-0049-x
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Article ; Online: Amyloid deposition and cognition in older adults: the effects of premorbid intellect.

Duff, Kevin / Foster, Norman L / Dennett, Kathryn / Hammers, Dustin B / Zollinger, Lauren V / Christian, Paul E / Butterfield, Regan I / Beardmore, Britney E / Wang, Angela Y / Morton, Kathryn A / Hoffman, John M

Archives of clinical neuropsychology : the official journal of the National Academy of Neuropsychologists

2013 Volume 28, Issue 7, Page(s) 665–671

Abstract: Although amyloid deposition remains a marker of the development of Alzheimer's disease, results linking amyloid and cognition have been equivocal. Twenty-five community-dwelling non-demented older adults were examined with (18)F-flutemetamol, an amyloid ... ...

Abstract	Although amyloid deposition remains a marker of the development of Alzheimer's disease, results linking amyloid and cognition have been equivocal. Twenty-five community-dwelling non-demented older adults were examined with (18)F-flutemetamol, an amyloid imaging agent, and a cognitive battery, including an estimate of premorbid intellect and the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS). In the first model, (18)F-flutemetamol uptake significantly correlated with the Delayed Memory Index of the RBANS (r = -.51, p = .02) and premorbid intellect (r = .43, p = .03). In the second model, the relationship between (18)F-flutemetamol and cognition was notably stronger when controlling for premorbid intellect (e.g., three of the five RBANS Indexes and its Total score significantly correlated with (18)F-flutemetamol, r's = -.41 to -.58). Associations were found between amyloid-binding (18)F-flutemetamol and cognitive functioning in non-demented older adults. These associations were greatest with delayed memory and stronger when premorbid intellect was considered, suggesting that cognitive reserve partly compensates for the symptomatic expression of amyloid pathology in community-dwelling elderly.
MeSH term(s)	Aged ; Aged, 80 and over ; Alzheimer Disease/diagnostic imaging ; Alzheimer Disease/metabolism ; Alzheimer Disease/pathology ; Amyloid/metabolism ; Brain/diagnostic imaging ; Brain/metabolism ; Brain/pathology ; Cognition/physiology ; Cognition Disorders/diagnostic imaging ; Cognition Disorders/metabolism ; Cognition Disorders/pathology ; Female ; Humans ; Male ; Neuropsychological Tests ; Positron-Emission Tomography
Chemical Substances	Amyloid
Language	English
Publishing date	2013-06-30
Publishing country	United States
Document type	Journal Article ; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't
ZDB-ID	632972-x
ISSN	1873-5843 ; 0887-6177
ISSN (online)	1873-5843
ISSN	0887-6177
DOI	10.1093/arclin/act047
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Zs.B 2993: Show issues

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Article ; Online: (18)F-FDG PET in the evaluation of acuity of deep vein thrombosis.

Rondina, Matthew T / Lam, Uyen T / Pendleton, Robert C / Kraiss, Larry W / Wanner, Nathan / Zimmerman, Guy A / Hoffman, John M / Hanrahan, Christopher / Boucher, Kenneth / Christian, Paul E / Butterfield, Regan I / Morton, Kathryn A

Clinical nuclear medicine

2012 Volume 37, Issue 12, Page(s) 1139–1145

Abstract: Purpose: F-FDG PET has been used for vascular disease, but its role in deep vein thrombosis (DVT) remains prospectively unexplored.: Patients and methods: Whole-body F-FDG PET/CT scans were performed in patients 1 to 10 weeks after onset of ... ...

Abstract	Purpose: F-FDG PET has been used for vascular disease, but its role in deep vein thrombosis (DVT) remains prospectively unexplored. Patients and methods: Whole-body F-FDG PET/CT scans were performed in patients 1 to 10 weeks after onset of symptomatic DVT (n = 12) and in control subjects without DVT (n = 24). The metabolic activity (SUVmax) of thrombosed and contralateral nonthrombosed vein segments was determined. The sensitivity and specificity of F-FDG PET/CT for the diagnosis of DVT were determined by receiver operating characteristic curve analyses. In 2 patients with DVT, changes in the metabolic activity of thrombosed vein segments in serial F-FDG PET scans. Results: The metabolic activity in thrombosed veins [SUVmax, 2.41 (0.75)] was visually appreciable and significantly higher than in nonthrombosed veins in either the contralateral extremity of patients with DVT [SUVmax, 1.09 (0.25), P = 0.007] or control subjects [1.21 (0.22), P < 0.001]. The area under the receiver operating characteristic curve for SUVmax was 0.9773 (P < 0.001), indicating excellent accuracy. An SUVmax threshold of greater than 1.645 was 87.5% sensitive and 100% specific for DVT. Metabolic activity in thrombosed veins correlated significantly with time from DVT symptom onset (decrease in SUVmax of 0.02/d, P < 0.05). Best-fit-line analyses suggested that approximately 84 to 91 days after acute DVT, the maximum metabolic activity of thrombosed veins would return to normal levels. Conclusions: F-FDG PET/CT is accurate for detecting acute symptomatic, proximal DVT. Metabolic activity in thrombosed veins decreases with time, suggesting that F-FDG PET may be helpful in assessing the age of the clot.
MeSH term(s)	Acute Disease ; Female ; Fluorodeoxyglucose F18 ; Humans ; Male ; Middle Aged ; Positron-Emission Tomography ; Sensitivity and Specificity ; Venous Thrombosis/diagnostic imaging ; Venous Thrombosis/metabolism
Chemical Substances	Fluorodeoxyglucose F18 (0Z5B2CJX4D)
Language	English
Publishing date	2012-11-16
Publishing country	United States
Document type	Clinical Trial ; Journal Article ; Research Support, N.I.H., Extramural
ZDB-ID	197628-x
ISSN	1536-0229 ; 0363-9762
ISSN (online)	1536-0229
ISSN	0363-9762
DOI	10.1097/RLU.0b013e3182638934
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Zs.A 1276: Show issues

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Article ; Online: Comparison of 18F-fluorodeoxyglucose and 18F-fluorothymidine PET in differentiating radiation necrosis from recurrent glioma.

Enslow, Michael S / Zollinger, Lauren V / Morton, Kathryn A / Butterfield, Regan I / Kadrmas, Dan J / Christian, Paul E / Boucher, Kenneth M / Heilbrun, Marta E / Jensen, Randy L / Hoffman, John M

Clinical nuclear medicine

2012 Volume 37, Issue 9, Page(s) 854–861

Abstract: Purpose: The objective was to compare F-fluorodeoxyglucose (FDG) and F-fluorothymidine (FLT) PET in differentiating radiation necrosis from recurrent glioma.: Materials and methods: Visual and quantitative analyses were derived from static FDG PET ... ...

Abstract	Purpose: The objective was to compare F-fluorodeoxyglucose (FDG) and F-fluorothymidine (FLT) PET in differentiating radiation necrosis from recurrent glioma. Materials and methods: Visual and quantitative analyses were derived from static FDG PET and static and dynamic FLT PET in 15 patients with suspected recurrence of treated grade 2 glioma or worse with a new focus of Gd contrast enhancement on MRI. For FDG PET, SUVmax and the ratio of lesion SUVmax to the SUVmean of contralateral white matter were measured. For FLT PET, SUVmax and Patlak-derived metabolic flux parameter Kimax were measured for the same locus. A 5-point visual confidence scale was applied to FDG PET and FLT PET. Receiver operating curve analysis was applied to visual and quantitative results. Differences between recurrent tumor and radiation necrosis were tested by Kruskal-Wallis analysis. On the basis of follow-up Gd-enhanced MRI, lesion-specific recurrent tumor was defined as a definitive increase in size of the lesion, and radiation necrosis was defined as stability or regression. Results: For FDG SUVmax, the FDG ratio of lesion-white matter, and FLT Kimax, there was a significant difference between mean values for recurrent tumor and radiation necrosis. Recurrent tumor was best identified by the FDG ratio of lesion-contralateral normal white matter (area under the curve of 0.98, confidence interval of 0.91 to 1.00, sensitivity of 100%, and specificity of 75% for an optimized cutoff value of 1.82). Conclusions: Both quantitative and visual determinations allow accurate differentiation between recurrent glioma and radiation necrosis by both FDG and FLT PET. In this small series, FLT PET offers no advantage over FDG PET.
MeSH term(s)	Adult ; Aged ; Diagnosis, Differential ; Dideoxynucleosides ; Female ; Fluorodeoxyglucose F18 ; Glioma/diagnostic imaging ; Glioma/pathology ; Humans ; Male ; Middle Aged ; Necrosis/diagnostic imaging ; Neoplasm Grading ; Positron-Emission Tomography/methods ; Radiation Injuries/diagnostic imaging ; Recurrence ; Young Adult
Chemical Substances	Dideoxynucleosides ; Fluorodeoxyglucose F18 (0Z5B2CJX4D) ; alovudine (PG53R0DWDQ)
Language	English
Publishing date	2012-08-10
Publishing country	United States
Document type	Clinical Trial ; Comparative Study ; Journal Article ; Research Support, N.I.H., Extramural
ZDB-ID	197628-x
ISSN	1536-0229 ; 0363-9762
ISSN (online)	1536-0229
ISSN	0363-9762
DOI	10.1097/RLU.0b013e318262c76a
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Article: Comparison of whole-body PET/CT, dedicated high-resolution head and neck PET/CT, and contrast-enhanced CT in preoperative staging of clinically M0 squamous cell carcinoma of the head and neck.

Rodrigues, Rosana S / Bozza, Fernando A / Christian, Paul E / Hoffman, John M / Butterfield, Regan I / Christensen, Carl R / Heilbrun, Marta / Wiggins, Richard H / Hunt, Jason P / Bentz, Brandon G / Hitchcock, Ying J / Morton, Kathryn A

Journal of nuclear medicine : official publication, Society of Nuclear Medicine

2009 Volume 50, Issue 8, Page(s) 1205–1213

Abstract: Unlabelled: The purpose of this study was to compare optimized whole-body (WB) and dedicated high-resolution contrast-enhanced PET/CT protocols and contrast enhanced CT in the preoperative staging of primary squamous cell carcinoma of the head and neck.! ...

Abstract	Unlabelled: The purpose of this study was to compare optimized whole-body (WB) and dedicated high-resolution contrast-enhanced PET/CT protocols and contrast enhanced CT in the preoperative staging of primary squamous cell carcinoma of the head and neck. Methods: A total of 44 patients with clinically M0 squamous cell carcinoma of the head and neck underwent primary tumor resection and neck dissection within 6 wk of diagnostic imaging. Imaging consisted of a standard WB PET/CT protocol without intravenous contrast enhancement, followed by a high-resolution dedicated head and neck (HN) PET/CT protocol, which included diagnostic-quality contrast-enhanced CT (CECT). Imaging results were compared with histopathology. A 5-point scale was used to designate primary tumor localization and the presence of lymph node metastasis on a per-patient and per-level basis. For cervical nodes, receiver-operating-characteristic curves were generated to determine the differences in performance between the WB and HN PET/CT protocols and CECT. Sensitivity, specificity, positive and negative predictive values, and accuracy were calculated for primary tumor and cervical nodes. Results: No statistical difference was observed between WB and HN PET/CT protocols, both of which significantly outperformed CECT, in the evaluation of the primary tumor. The performance of the HN PET/CT protocol was superior to that of the WB PET/CT in the detection of cervical node metastases, achieving statistical significance on a per-level basis and approaching significance on a per-patient basis, with the greatest advantage in the detection of small positive lymph nodes (<15 mm). No significant difference was observed between the WB PET/CT protocol and CECT in nodal staging, either on a per-patient or on a per-level basis. Conclusion: The primary advantage of the dedicated HN PET/CT protocol over the WB protocol or CECT in the staging of head and neck cancer is in the detection of small lymph node metastases.
MeSH term(s)	Adult ; Aged ; Aged, 80 and over ; Carcinoma, Squamous Cell/diagnosis ; Carcinoma, Squamous Cell/secondary ; Carcinoma, Squamous Cell/surgery ; Contrast Media ; Head and Neck Neoplasms/diagnosis ; Head and Neck Neoplasms/surgery ; Humans ; Image Enhancement/methods ; Lymphatic Metastasis ; Middle Aged ; Neoplasm Staging ; Positron-Emission Tomography/methods ; Preoperative Care ; Reproducibility of Results ; Sensitivity and Specificity ; Subtraction Technique ; Tomography, X-Ray Computed/methods ; Whole Body Imaging/methods
Chemical Substances	Contrast Media
Language	English
Publishing date	2009-08
Publishing country	United States
Document type	Comparative Study ; Evaluation Studies ; Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	80272-4
ISSN	1535-5667 ; 0161-5505 ; 0097-9058 ; 0022-3123
ISSN (online)	1535-5667
ISSN	0161-5505 ; 0097-9058 ; 0022-3123
DOI	10.2967/jnumed.109.062075
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Article ; Online: SNMMI Clinical Trials Network Research Series for Technologists: Clinical Research Primer- Use of Imaging Agents in Therapeutic Drug Development and Approval.

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Article ; Online: Prospective Pilot Study of

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Article ; Online: FDG and FLT-PET for Early measurement of response to 37.5 mg daily sunitinib therapy in metastatic renal cell carcinoma.

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Article ; Online: Amyloid deposition and cognition in older adults: the effects of premorbid intellect.

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Article ; Online: (18)F-FDG PET in the evaluation of acuity of deep vein thrombosis.

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Article ; Online: Comparison of 18F-fluorodeoxyglucose and 18F-fluorothymidine PET in differentiating radiation necrosis from recurrent glioma.

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Article: Comparison of whole-body PET/CT, dedicated high-resolution head and neck PET/CT, and contrast-enhanced CT in preoperative staging of clinically M0 squamous cell carcinoma of the head and neck.

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