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ACTIVE NOT RECRUITING
NCT05936658
PHASE3

[18F]Florastamin PET/CT Imaging Examination in Patients With Suspected Recurrent or Metastatic Prostate Cancer

Sponsor: FutureChem

View on ClinicalTrials.gov

Summary

This is a multi-center, open-label, single arm Phase III clinical trial for the diagnostic efficacy assessment and safety evaluation by \[18F\]Florastamin PET/CT imaging examination to determine the presence of recurrent or metastatic prostate cancer in patients whose recurrent or metastatic lesions have been confirmed through the conventional imaging.

Official title: A Multi-center, Open-label, Single Arm Phase III Clinical Trial for the Diagnostic Efficacy Assessment and Safety Evaluation by [18F]Florastamin PET/CT Imaging Examination in Patients With Suspected Recurrent or Metastatic Prostate Cancer

Key Details

Gender

MALE

Age Range

19 Years - Any

Study Type

INTERVENTIONAL

Enrollment

138

Start Date

2023-05-08

Completion Date

2025-06

Last Updated

2025-03-12

Healthy Volunteers

No

Interventions

DRUG

[F-18]Florastamin

A single dose of \[F-18\]Florastamin at 10 ± 1 mCi is intravenously administered only to the subjects who meet the inclusion/exclusion criteria, and then \[F-18\]Florastamin PET/CT imaging is performed from the head to thigh after 105 ± 15 minutes (care should be taken to prevent extravasation of the radiopharmaceutical product).

Locations (6)

National Cancer Center

Gyeonggi-do, South Korea

Korea University Anam Hospital

Seoul, South Korea

Samsung Medical Center

Seoul, South Korea

Severance Hospital

Seoul, South Korea

The Catholic University of Korea, Seoul St. Mary's Hospital

Seoul, South Korea

Ewha womans university mokdong medical center

Soeul, South Korea