11C- and 18F-Choline PET/MR Imaging for Prostate Cancer
NCT ID: NCT02397408
Last Updated: 2020-11-19
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
18 participants
INTERVENTIONAL
2015-04-09
2015-06-30
Brief Summary
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Detailed Description
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I. To assess the ability of 11C- and 18F-choline PET/MR to detect and localize prostate cancer within the prostate gland.
SECONDARY OBJECTIVES:
I. To assess the ability of 11C- and 18F-choline PET/MR to detect the specific location of metastatic prostate cancer within pelvic lymph node regions in patients undergoing radical prostatectomy and extended pelvic lymph node dissection.
II. To assess the comparative performance of 11C- and 18F-choline PET/MR to already available imaging scans (bone scan, sodium fluoride positron emission tomography/computed tomography \[NaF PET/CT\], multiparametric1H magnetic resonance imaging \[MRI\], and/or pelvic CT scans) for detecting and localization of disease within the prostate, lymph nodes, and distant metastatic sites.
III. To determine the temporal distribution of 11C- and 18F-choline radiotracer in patients. The tissue uptake, retention, and clearance will be determined.
EXPLORATORY OBJECTIVES:
I. To compare regions of uptake on the 11C- and 18F-choline PET/MR to that on the sentinel lymph node imaging scans in patients undergoing sentinel lymph node-guided extended pelvic lymph node dissection.
OUTLINE:
Patients undergo 11C- and 18F-choline whole-body PET/MR imaging. After completion of study treatment, patients are followed up for 3 hours
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Diagnostic 11C- and 18F-choline PET/MR imaging
Patients are given 370 megabecquerel (MBq) 11C-Choline (11C) intravenously and 3 MBq/kg 18F-Choline (18F) intravenously prior to a whole-body PET/MR imaging
Carbon C 11 Choline
Given intravenously (IV) prior to imaging
Fluorine F 18 Choline
Given intravenously (IV) prior to imaging
Positron Emission Tomography (PET) / Magnetic Resonance Imaging (MRI)
Undergo whole-body PET/MR imaging
Interventions
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Carbon C 11 Choline
Given intravenously (IV) prior to imaging
Fluorine F 18 Choline
Given intravenously (IV) prior to imaging
Positron Emission Tomography (PET) / Magnetic Resonance Imaging (MRI)
Undergo whole-body PET/MR imaging
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Diagnosis: Patients must have a diagnosis of prostate cancer by histologic verification and a hypoechoic lesion seen on ultrasound.
* Disease Status: Unfavorable intermediate to high-risk prostate cancer, per the Cancer of the Prostate Risk Assessment Score (CAPRA) (CAPRA 5-10)
* Karnofsky Performance Status \>=70
* Metastatic workup: Whole Body Sodium Fluoride (NaF) PET/CT or 99mTc Bone Scan
* Planned to undergo radical prostatectomy and extended pelvic lymph node dissection
* Adequate bone marrow and organ function defined as follows:
* Adequate bone marrow function:
* Leukocytes \>= 3,000/microliter (mcL)
* Absolute Neutrophil Count \>= 1,500/mcL
* Platelets \>= 100,000/mcL
* Adequate hepatic function:
* Total bilirubin - within normal institutional limits
* Aspartate aminotransferase (AST)/ serum glutamic-oxaloacetic transaminase (SGOT) \<= 2.5 X institutional upper limit of normal
* Alanine aminotransferase (ALT)/serum glutamic-pyruvic transaminase (SGPT) \<= 2.5 X institutional upper limit of normal
* Adequate renal function:
* Creatinine - within normal institutional limits OR
* Creatinine clearance \>= 60 mL/min/ 1.73m2 for patients with creatinine levels above institutional normal
* Ability to understand a written informed consent document, and the willingness to sign it
Exclusion Criteria
* Karnofsky performance status of \< 60
* Inadequate venous access
* Administered a radioisotope within 5 physical half lives prior to study enrollment
* Have a medical condition or other circumstances which, in the opinion of the investigator would significantly decrease the chances of obtaining reliable data, achieving the study objectives, or completing the study.
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
University of California, San Francisco
OTHER
Responsible Party
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Albert J. Chang, MD, PhD
Assistant Professor
Principal Investigators
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Albert J Chang, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of California, San Francisco
Locations
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University of California San Francisco
San Francisco, California, United States
Countries
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References
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Choi JY, Yang J, Noworolski SM, Behr S, Chang AJ, Simko JP, Nguyen HG, Carroll PR, Kurhanewicz J, Seo Y. 18F Fluorocholine Dynamic Time-of-Flight PET/MR Imaging in Patients with Newly Diagnosed Intermediate- to High-Risk Prostate Cancer: Initial Clinical-Pathologic Comparisons. Radiology. 2017 Feb;282(2):429-436. doi: 10.1148/radiol.2016160220. Epub 2016 Aug 11.
Related Links
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Link to Publication for NCT02397408
Other Identifiers
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NCI-2015-00731
Identifier Type: REGISTRY
Identifier Source: secondary_id
145511
Identifier Type: -
Identifier Source: org_study_id