A Phase 2 Study of 18F FTC 146 PET/CT in Patients With Newly Diagnosed Osteosarcoma
Trial Snapshot
- Phase
- Phase 2
- Status
- Terminated
- Sponsor
- Enrollment
- 1
- Locations
- 1
- Primary Endpoint
- Detection of Tumor Necrosis Post-chemotherapy
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients with biopsy proven osteosarcoma requiring local surgical intervention.
- •Ability to understand and the willingness to sign a written informed consent document.
Exclusion Criteria
- •Chemotherapy in the past 2 months.
- •Prior history of allergic reaction to 18F FTC
- •Pregnant or nursing
Arms & Interventions
18-F-FTC 146 PET/CT
For PET scans, subjects will receive intravenous injection of 10 mCi 18-F -FTC 146 administered twice with 18-F-FTC 146, once at baseline (pre chemotherapy) and once at final study visit (post chemotherapy).
Intervention: 18-F FTC 146 (Drug)
Outcomes
Primary Outcomes
Detection of Tumor Necrosis Post-chemotherapy
Time Frame: 12 weeks
Participants will be assessed with 18F FTC 146 PET/CT imaging at baseline and after neoadjuvant (pre surgery) chemotherapy but before surgery itself. Chemotherapy will be nominally three 3 week cycles administered over up to 12 weeks. The ability of 18F FTC 146 PET/CT to evaluate treatment effect will be assessed as the percentage of tumor that is assessed as necrotic after the treatment course. The outcome will be reported as the mean percentage of the resected tumor (removed by surgery) that is assessed by histopathology as necrotic, with standard deviation.
Secondary Outcomes
- Maximum Standardized Uptake Value (SUVmax)(12 weeks)
- Use of Patient Reported Outcomes Measurement Information System (PROMIS) to Assess Treatment Effect(12 weeks)
Investigators
Kristen Ganjoo
Professor of Medicine (Oncology)
Stanford University