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RECRUITING
NCT05799248
PHASE3

Role of rhPSMA-7.3 PET/CT Imaging in Men With High-Risk Prostate Cancer Following Conventional Imaging and Associated Changes in Medical Management

Sponsor: MidLantic Urology

View on ClinicalTrials.gov

Summary

Study Title: Role of rhPSMA-7.3 PET/CT imaging in men with High-Risk prostate cancer following conventional imaging and associated changes in medical management Protocol number: BED-IIT-437 Phase: 3b Sponsor: MidLantic Urology Funding Organization: Blue Earth Diagnostics Ltd Study Design: This is a Phase 3b, multi-center, single-arm, diagnostic imaging study designed to detect metastatic lesions in men diagnosed with high-risk prostate cancer.

Key Details

Gender

MALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

113

Start Date

2023-04-27

Completion Date

2024-05-28

Last Updated

2024-05-24

Healthy Volunteers

No

Conditions

Interventions

DRUG

rhPSMA-7.3 (18F)

Patients will receive a dose with an administered activity of 8 mCi (296 MBq) ± 20% of rhPSMA-7.3, delivered as an IV bolus injection with a 10 mL fast 0.9% sodium chloride flush, followed by PET imaging.

Locations (1)

MidLantic Urology

Bala-Cynwyd, Pennsylvania, United States