NCT05516329

Study of 18F-Thretide PET/CT in Patients With Prostate Cancer

A Study to Assess the Diagnostic Performance of 18F-Thretide PET/CT in Men With Prostate Cancer

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 49 (actual)
• Sponsor: First Affiliated Hospital of Fujian Medical University · Academic / Other
• Sex: Male
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This study evaluates the diagnostic performance and safety of 18F-Thretide PET/CT in patients with biopsy proven prostate cancer who has no any form of therapy against prostate caner or suspected recurrence of prostate cancer who have negative or equivocal findings on conventional imaging.

Detailed description

Prostate-specific membrane antigen (PSMA) is overexpressed in most cases of prostate cancer and is potentially associated with metastasis and progression of prostate cancer. Compared with 68Ga, the PET radionuclide 18F exhibits several advantages. 18F-Thretide (18F-labeled PSMA ligand) has been studied for preclinical evaluation and Pilot Clinical Study. This study evaluates the diagnostic performance and safety of 18F-Thretide PET/CT in patients with with biopsy proven prostate cancer who has no any form of therapy against prostate caner or suspected recurrence of prostate cancer who have negative or equivocal findings on conventional imaging.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DRUG	A single dose of 7±1 mCi (259±37 MBq) IV injection of 18F-Thretide	The patients will be intravenously injected with 18F-Thretide and undergo PET/CT scan at 60\~120 min after the injection.

Timeline

• Start date: 2022-08-20
• Primary completion: 2023-03-31
• Completion: 2023-09-01
• First posted: 2022-08-25
• Last updated: 2023-09-21

Locations

1 site across 1 country: China