Evaluation of 18F-DCFBC PSMA-based PET Imaging for Detection of Metastatic Prostate Cancer
This research is being done to see if an investigational radioactive drug called 18F-DCFBC can help us find cancer that has spread (metastatic disease) from its original site in people who have cancer in their prostate to other parts of their body.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||Evaluation of 18F-DCFBC PSMA-based PET Imaging for Detection of Metastatic Prostate Cancer.|
- PET/CT detection of Metastatic Prostate Cancer [ Time Frame: 24 Months ] [ Designated as safety issue: No ]To compare the diagnostic accuracy of DCFBC PET to CIM (CT and bone scintigraphy) for detection of metastatic prostate cancer based on comparison to dynamic CIM incorporating prior and follow-up scans..
- Measurement of new or progressive disease [ Time Frame: 24 Months ] [ Designated as safety issue: No ]Estimate the proportion of new or progressive metastatic lesions found on conventional imaging modalities (CIM) that are DCFBC PET positive. Estimate the proportion of DCFBC PET positive sites that are positive for new or progressive metastatic disease by conventional imaging modalities (CIM) for prostate cancer.
|Study Start Date:||March 2013|
|Estimated Study Completion Date:||January 2015|
|Estimated Primary Completion Date:||January 2015 (Final data collection date for primary outcome measure)|
Other Name: A bolus of 10 mCi (370 MBq) [9-11 mCi (333-407 MBq)] of 18F-DCFBC will be injected into the IV line by slow IV push.
The objective of this study is to evaluate a radiolabeled urea-based small molecule inhibitor of prostate-specific membrane antigen (PSMA), [18F]DCFBC (DCFBC) PET imaging for detection of metastatic prostate cancer. PSMA is a well characterized histological marker of prostate cancer tumor aggressiveness and metastatic potential. The investigators propose to assess the ability of DCFBC PET to detect metastatic prostate cancer by visual qualitative and quantitative SUV analysis. Correlation will be made to sites of suspected metastatic disease detected by standard conventional imaging modalities (CIM) for prostate cancer which includes IV contrast CT of chest/abdomen/pelvis and whole body bone scintigraphy.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01815515
|United States, Maryland|
|Johns Hopkins University|
|Baltimore, Maryland, United States, 21287|
|Principal Investigator:||Steve Y Cho, M.D||Johns Hopkins University|