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The Safety and Efficacy of 18F-Fluoromethylcholine (18F-FCH) PET/CT in Prostate Cancer

NCT02840552 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2018-08-09

No results posted yet for this study

Summary

The objectives of this study are to confirm the safety and efficacy of FCH-PET/CT and to establish our ability to reproduce results from the literature using FCH-PET/CT as a diagnostic and decision making tool in the management in two predefined groups of prostate cancer patients, specifically, biochemical recurrence and high risk staging. The primary endpoints of the study are the incidence of adverse events (AE) in the study population up to 24 hours following the scan, and the sensitivity and specificity of FCH-PET/CT vs CT on a per-patient and per-lesion basis.

Conditions

Interventions

DRUG

18F-Fluoromethylcholine (18F-FCH)

FCH PET/CT

Sponsors & Collaborators

  • Sir Mortimer B. Davis - Jewish General Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
120 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-09-30
Primary Completion
2018-02-28
Completion
2018-03-31

Countries

  • Canada

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 NCT02840552 on ClinicalTrials.gov