CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 18 enrolled
Drug / intervention
Carbon C 11 Choline +2 moredrug
Likely dose
Not stated in record
Key inclusion· 6
  • ✓Age ≥18 years
  • ✓Histologically confirmed prostate cancer with hypoechoic lesion on ultrasound
  • ✓Unfavorable intermediate to high-risk disease (CAPRA score 5-10)
  • ✓Karnofsky Performance Status ≥70
Key exclusion· 4
  • ✕Karnofsky performance status <60
  • ✕Participation would significantly delay scheduled standard-of-care therapy
  • ✕Inadequate venous access for tracer injection
  • ✕Radioisotope administered within 5 physical half-lives prior to enrollment

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02397408
NCT02397408Phase 2Completed
CompareCT.gov

Phase 2 Study of 11C- and 18F-Choline PET/MR Imaging in Patients With Unfavorable Intermediate to High-Risk Prostate Cancer

University of California, San Francisco·interventional·Posted Mar 25, 2015·Updated Nov 19, 2020

In Brief

A Phase 2 clinical trial evaluating Carbon C 11 Choline, Fluorine F 18 Choline, and 1 other intervention for Prostate Cancer. Completed, enrolled 18 participants across 1 site.

Detailed Summary

This phase II trial studies how well 11C-choline (carbon C 11 choline) and 18F-choline (fluorine F 18 choline) positron emission tomography/magnetic resonance (PET/MR) imaging works in diagnosing patients with unfavorable intermediate to high-risk prostate cancer. Diagnostic procedures, such as 11C- and 18F-choline PET/MR may help find and diagnose prostate cancer and find out how far the disease has spread.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsProstate Cancer
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI)

Timeline

Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedMar 25, 2015
Enrollment StartApr 9, 2015
Primary CompletionJun 30, 2015
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 11.3 years ago

Interventions

Carbon C 11 Cholinedrug

Given intravenously (IV) prior to imaging

Fluorine F 18 Cholinedrug

Given intravenously (IV) prior to imaging

Positron Emission Tomography (PET) / Magnetic Resonance Imaging (MRI)procedure

Undergo whole-body PET/MR imaging