NCT04365660

18F-FTC-146 PET/CT in Newly-Diagnosed Osteosarcoma

A Phase 2 Study of 18F FTC 146 PET/CT in Patients With Newly Diagnosed Osteosarcoma

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: Davidzon, Guido, M.D. · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this research is to evaluate the study drug, 18F FTC-146, as a positron emission tomography (PET) / computed tomography (CT) radiotracer imaging agent to evaluate tumor status in patients newly diagnosed with osteosarcoma ("bone cancer").

Detailed description

Primary Objective: Demonstrate correlation of pre-post reduction in 18F-FTC-146 PET/CT with amount of post-treatment tumor necrosis in newly-diagnosed and treated osteosarcoma patients. Secondary Objective: Demonstrate correlation of pre-post reduction in 18F-FTC-146 PET/CT with amount of post-treatment pain reduction in newly-diagnosed and treated osteosarcoma patients.

Conditions

• Osteosarcoma

Interventions

Type	Name	Description
DRUG	18-F FTC 146	Radiotracer, 10 mCi at pre- and post- chemotherapy, intravenous administration

Timeline

• Start date: 2021-01-28
• Primary completion: 2021-05-28
• Completion: 2021-07-22
• First posted: 2020-04-28
• Last updated: 2023-11-14
• Results posted: 2023-11-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study