NCT03453528

Investigation of PSMA PET/CT as an Imaging Biomarker in Solid Tumors

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,225 (actual)
• Sponsor: Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

multi-centre, prospective, diagnostic trial to evaluate the Prostate-Specific Membrane Antigen (PSMA-antigen) over-expression in metastatic castration resistant prostate cancer (mCRPC) and in advanced/metastatic solid tumors patients.

Detailed description

Multi-centre, prospective, diagnostic trial to evaluate the Prostate-Specific Membrane Antigen (PSMA-antigen) over-expression in metastatic castration resistant prostate cancer (mCRPC) and in advanced/metastatic solid tumors patients. The primary objective of this study is to evaluate the detection rate of PSMA PET/CT, defined as the ratio of PSMA-positive patients and the total number of cancer patients with known advanced/metastatic disease that performed a PSMA PET/CT as part of the present study. A positive patient is defined as a patient with at least one PSMA-positive lesion.

Conditions

• Prostate-specific Membrane Antigen
• mCRPC or Advanced/Metastatic Solid Tumors

Interventions

Type	Name	Description
DRUG	68Ga-PSMA	68Ga-PSMA will be injected intravenously via an indwelling catheter in an antecubital vein; (68Ga-PSMA activity: min 100 MBq - max 200 MBq, weighted activity: 2.0 MBq/Kg).

Timeline

• Start date: 2017-07-04
• Primary completion: 2024-12-04
• Completion: 2025-01-03
• First posted: 2018-03-05
• Last updated: 2025-01-08

Locations

1 site across 1 country: Italy