CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 16 enrolled
Drug / intervention
68Ga-PSMA-generator vs. 68Ga-PSMA-cyclotrondrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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

Search/NCT04685811
NCT04685811Phase 2Completed
CompareCT.gov

Evaluation of a 68Ga Small Molecule PSMA Antagonist Produced by Two Different Methods

Weill Medical College of Cornell University·interventional·Posted Dec 28, 2020·Updated Sep 22, 2022

In Brief

A Phase 2 clinical trial evaluating 68Ga-PSMA-generator vs. 68Ga-PSMA-cyclotron for Metastatic Prostate Adenocarcinoma. Completed, enrolled 16 participants across 1 site.

Detailed Summary

Patients with metastatic prostate cancer will undergo two protocol 68Ga-PET scans within 24-48 hours with 68Ga-PSMA-cyclotron and 68Ga-PSMA-generator radiotracers. The goal of the study is to evaluate repeatability and equivalence across the different 68Ga-PSMA production methods. This research study is being conducted to assess whether the PET/CT imaging results, as generated from the two different 68Ga production methods, are equivalent.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMetastatic Prostate Adenocarcinoma
CountriesUnited States
CollaboratorsNational Institutes of Health (NIH), National Cancer Institute (NCI)

Timeline

Phase 2CompletedFinished
202120222023202420252026
First PostedDec 28, 2020
Enrollment StartDec 9, 2020
Primary CompletionJun 30, 2021
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 5.5 years ago

Interventions

68Ga-PSMA-generator vs. 68Ga-PSMA-cyclotrondrug

68Ga-PSMA-generator vs. 68Ga-PSMA-cyclotron; single dose each, approximately 100-300 mBq.