Clinical Trials Directory

Trials / Completed

CompletedNCT03698370

Gallium Ga 68 DOTA-NeoBOMB1 and Gallium Ga 68 PSMA-R2 PET/MRI in Diagnosing Participants With Recurrent Prostate Cancer

68Ga-NeoBOMB1 and 68Ga-PSMA R2 PET/MRI in the Evaluation of Patients With Biochemical Recurrence of Prostate Cancer

Status
Completed
Phase
Phase 2
Study type
Interventional
Enrollment
27 (actual)
Sponsor
Andrei Iagaru · Academic / Other
Sex
Male
Age
18 Years
Healthy volunteers
Not accepted

Summary

This phase II trial studies how well gallium Ga 68 DOTA-NeoBOMB1 and gallium Ga 68 PSMA-R2 positron emission tomography (PET)/magnetic resonance imaging (MRI) work in diagnosing participants with prostate cancer that has come back. Diagnostic procedures, such as gallium Ga 68 DOTA-NeoBOMB1 and gallium Ga 68 PSMA-R2 PET/MRI, may help find and diagnose prostate cancer and find out how far the disease has spread.

Detailed description

PRIMARY OBJECTIVES: I. To evaluate gallium Ga 68 DOTA-NeoBOMB1 (68Ga-NeoBOMB1) and gallium Ga 68 PSMA-R2 (68Ga-PSMA R2) PET/MRI for detection of recurrent prostate cancer after initial therapy in patients meeting the criterion of biochemical recurrence. OUTLINE: Participants are randomized to 1 of 2 arms. ARM I: Participants receive gallium Ga 68 DOTA-NeoBOMB1 intravenously (IV) and 45 minutes later, undergo PET/MRI. Within 2 weeks, participants receive gallium Ga 68 PSMA-R2 IV then undergo PET/MRI 45-60 minutes later. ARM II: Participants receive gallium Ga 68 PSMA-R2 IV and 45-60 minutes later undergo PET/MRI. Within 2 weeks, participants receive gallium Ga 68 DOTA-NeoBOMB1 IV then undergo PET/MRI 45 minutes later. After completion of study, participants are followed up at 12 months.

Conditions

Interventions

TypeNameDescription
DRUGGallium Ga 68 DOTA-NeoBOMB1Administered intravenously (IV)
DEVICEGallium Ga 68 PSMA-R2Administered intravenously (IV)

Timeline

Start date
2020-12-15
Primary completion
2022-02-11
Completion
2022-02-11
First posted
2018-10-09
Last updated
2024-01-30
Results posted
2024-01-30

Locations

1 site across 1 country: United States

Regulatory

Source: ClinicalTrials.gov record NCT03698370. Inclusion in this directory is not an endorsement.