NCT04528199

[18F]FLOR (FC303) PET/CT Imaging in Patients With Prostate Cancer

A Phase 1 Study of [18F]FLOR (FC303) PET/CT Imaging in Patients With Prostate Cancer

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The study is an open label, single-arm study designed to evaluate the safety and diagnostic performance of \[18F\]FLOR (FC303) PET/CT imaging to determine the presence or absence of metastatic prostate cancer. .

Detailed description

This research is being done to determine whether the radioactive compound called \[18F\]FLOR (FC303) is safe and well-tolerated in patients with metastatic prostate cancer. Participants in this study will have tests, exams and procedures that are for study purposes. Participants will be in this study up to one month which will include up to three clinic visits. Eligible patients diagnosed with metastatic prostate cancer will undergo a \[18F\]FLOR (FC303) PET-CT scan. This is the imaging procedure to assess where \[18F\]FLOR (FC303) has accumulated in the body.

Conditions

• Metastatic Prostate Cancer

Interventions

Type	Name	Description
DRUG	[18F]FLOR (FC303) Injection	Single dose of 10 ±1 millicurie (mCi) of \[18F\]FLOR (FC303) injection followed by the PET/CT scan.

Timeline

• Start date: 2021-02-01
• Primary completion: 2023-04-21
• Completion: 2023-04-21
• First posted: 2020-08-27
• Last updated: 2024-01-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study