PET/CT Imaging Study of the Safety and Diagnostic Performance of [68Ga]RM2 in Patients With Primary Prostate Cancer
Status:
Terminated
Trial end date:
2016-12-01
Target enrollment:
Participant gender:
Summary
The aim of this study is to investigate safety and diagnostic performance of the 68Ga labeled
PET tracer [68Ga]RM2 for detection and localization of primary prostate cancer confirmed by
histopathology of the prostate as a standard of truth.
This is an open-label, multi center PET/CT (positron emission tomography/computed tomography)
non-randomized study. The study comprises 2 parts with an interim analysis after Part 1. In
Part 1 a total of 30 subjects with biopsy-proven primary prostate cancer will be enrolled.
Three strata of patients for the first part will be enrolled based on their pretreatment
recurrence risk assessment according to the NCCN guidelines: 10 patients with low, 10
patients with intermediate and 10 patients with high pretreatment risk of recurrence.
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
Life Molecular Imaging SA Piramal Imaging SA
Treatments:
Bombesin Molecular Mechanisms of Pharmacological Action