CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 225 enrolled
Drug / intervention
Ga-68 labeled HBED-CC PSMA +2 moredrug
Likely dose
Ga-68 labeled HBED-CC PSMA 25 μgfrom 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/NCT02611882
NCT02611882Phase 2Completed

Evaluation of Gallium-68 HBED-CC-PSMA Imaging in Prostate Cancer Patients

Thomas Hope·interventional·Posted Nov 23, 2015·Updated Dec 22, 2020

In Brief

A Phase 2 clinical trial evaluating Ga-68 labeled HBED-CC PSMA, Positron Emission Tomography (PET) image combined with Computed Tomography (CT) (PET/CT), and 1 other intervention for Prostate Cancer. Completed, enrolled 225 participants across 1 site.

Detailed Summary

The investigators are imaging patients with prostate cancer using a new PET imaging agent (Ga-68 HBED-CC PSMA) in order to evaluate it's ability to detection prostate cancer in patients with high risk disease prior to prostatectomy, patients with biochemical recurrence and patients with castrate resistant prostate cancer.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsProstate Cancer
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedNov 23, 2015
Enrollment StartDec 18, 2015
Primary CompletionOct 24, 2016
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 10.6 years ago

Interventions

Ga-68 labeled HBED-CC PSMAdrug

The imaging agent (Ga-68 HBED-CC PSMA) will be administered on an outpatient basis. It will be administered a single time intravenously prior to the PET/CT imaging. The one-time nominal injected dose will be 3 to 7 millicurie (mCi) containing 10 - 25 μg Ga-68 HBED-CC PSMA.

Positron Emission Tomography (PET) image combined with Computed Tomography (CT) (PET/CT)device

Patient shall begin imaging between 55 and 70 minutes after the injection of the radiopharmaceutical. A PET/CT scan includes two parts: a PET scan and a CT scan. The CT portion of the scan produces a 3-D image that shows a patient's anatomy. The PET scan demonstrates function and what's occurring on a cellular level. The PET scan is unique because it images the radiation emitted from the patient while the CT records anatomical x-rays, showing the same area from another perspective

Positron Emission Tomography (PET) image combined with Magnetic Resonance Imaging (MRI) (PET/MRI)device

Patient shall begin imaging between 55 and 70 minutes after the injection of the radiopharmaceutical. A PET/MRI scan is a two-in-one test that combines images from a positron emission tomography (PET) scan and a magnetic resonance imaging (MRI) scan. Coverage for the scan will extend from the patients vertex through the mid thighs. We will use 4 minute acquisitions per bed position for PET imaging.