At a glance
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NCT04053842Phase 2ActiveUpdate OverdueUpdated 15mo ago · Completion was 29mo agoMulti-modality Prostate Cancer Image Guided Interventions - 5
In Brief
A Phase 2 clinical trial evaluating PET Scan, [18F]PSMA-1007 Injection, and 2 other interventions for Prostate Cancer and 2 related conditions. Active but no longer recruiting, targeting 45 participants across 1 site.
Signals
Detailed Summary
The study is a non-randomized, prospective trial of men scheduled for radical prostatectomy for treatment of prostate cancer as standard of care and will undergo a series of pre-operative multi-modality imaging studies. Pre-operative imaging will be correlated with actual pathology results and statistical modeling performed to determine the most informative imaging biomarkers in predicting cancer location and aggressiveness (Gleason Score).
Study Details
Timeline
Interventions
PET imaging uses small amounts of a radioactive substance called a tracer to look for disease in the body. The radioactive substance used in this study is \[18F\]PSMA-1007.
\[18F\]PSMA-1007 is given by intravenous (IV) injection into the arm. It travels through the blood stream where it is rapidly taken up by prostate cancer cells and emits tiny, positively charged particles (called positrons) that produce signals into the body. These signals are detected by the PET component of the PET/MRI scanner.
Sodium MRI uses magnetic waves and a specially-designed rectal probe to measure the sodium concentration (amount of salt) in the prostate. Previous research has shown that higher sodium concentrations in the prostate might be a sign of more aggressive cancer.
MRI is a common medical diagnostic tool that uses magnetic waves and a contrast agent (dye) called Gadovist to take pictures of body tissue.