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PET/CT Imaging Study of the Safety and Diagnostic Performance of [68Ga]RM2 in Patients With Primary Prostate Cancer

NCT02483884 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2017-03-22

No results posted yet for this study

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.

Conditions

Interventions

DRUG

[68Ga]RM2

\[68Ga\]RM2 is a novel 68Ga labeled, radiopharmaceutical agent for PET imaging. It is administered intravenously as a single dose of 140 MBq (corresponding to ≤ 40 μg mass dose)

PROCEDURE

PET/CT

Patients received \[68Ga\]RM2 undergo PET/CT 60 min p.i. for at least 20 min

Sponsors & Collaborators

  • Life Molecular Imaging SA

    lead INDUSTRY

Principal Investigators

  • Andrew Stephens, MD, PhD · Piramal Imaging GmbH

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
45 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-05-31
Primary Completion
2016-12-31
Completion
2016-12-31

Countries

  • Austria
  • Finland

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02483884 on ClinicalTrials.gov