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

Phase 2

Waitlist Available

Research Sponsored by Andrei Iagaru

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 1 year post-scan follow-up

Awards & highlights

No Placebo-Only Group

Summary

This trial studies how well two special imaging agents combined with PET/MRI scans work in detecting prostate cancer that has returned after initial treatment. It targets patients whose cancer has come back, using the agents to highlight cancer cells on the scans.

Eligible Conditions

Prostate Adenocarcinoma
Prostate Cancer
Prostate-Specific Antigen

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 1 year post-scan follow-up

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 1 year post-scan follow-up

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 1 year post-scan follow-up for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of Lesions Detected by Investigational Imaging Agent

Secondary study objectives

Number of Detected Lesions Confirmed to be Malignant for Each Imaging Method

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Arm II (Ga68 PSMA-R2 and Ga 68-NeoBOMB1)Experimental Treatment2 Interventions

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.

Group II: Arm I (Ga68-NeoBOMB1 and Ga68 PSMA-R2Experimental Treatment2 Interventions

Participants receive gallium Ga 68 DOTA-NeoBOMB1 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Gallium Ga 68 DOTA-NeoBOMB1

2020

Completed Phase 2

~30

Gallium Ga 68 PSMA-R2

2020

Completed Phase 2

~30