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Ga-68-PSMA-11 in Men With Prostate Cancer

NCT05744115 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2023-02-24

No results posted yet for this study

Summary

The purpose of this study is to provide access to Ga-68-PSMA-11 PET for evaluation of male veterans with newly diagnosed or biochemically recurrent prostate cancer. All patients will receive conventional imaging (MRI, CT, and/or a molecular imaging bone scan) as well as Ga-68-PSMA-11 PET in order to evaluate the utility of diagnostic testing in patients with positive PSA status, a comparison of results from conventional imaging and PSMA PET imagining will be performed.

Conditions

Interventions

DRUG

Ga-68-PSMA-11

Ga-68-PSMA-11 is produced via a lyophilized Sterile Cold kit. Ga-68 is eluted from a Ge-68/Ga-68 generator into a vial containing the premixed peptide and buffer. PSMA-11 radiolabeled with Ga-68 is administered to patients following verification of standard quality controls including activity measurement, pH, radiochemical purity, and visual inspection

Sponsors & Collaborators

  • Harry S. Truman Memorial Veterans' Hospital

    collaborator FED

  • University of Missouri-Columbia

    collaborator OTHER

  • Telix Pharmaceuticals, Ltd

    collaborator UNKNOWN

  • Timothy Hoffman

    lead FED

Principal Investigators

  • Timothy J Hoffman, PhD · Truman VA Hospital; Columbia, MO

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-27
Primary Completion
2022-04-14
Completion
2022-04-14
FDA Drug
Yes

Countries

  • United States

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 NCT05744115 on ClinicalTrials.gov