Back to results18F-FTC-146 PET/CT in Newly-Diagnosed Osteosarcoma
Primary Purpose
Osteosarcoma
Status
Active
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
18-F FTC 146
Sponsored by
About this trial
This is an interventional diagnostic trial for Osteosarcoma
Eligibility Criteria
Inclusion Criteria:
- Patients with biopsy proven osteosarcoma requiring local surgical intervention.
- ECOG ≤ 2
- 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 146.
- Pregnant or nursing
Sites / Locations
- Stanford University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
18-F-FTC 146 PET/CT
Arm Description
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).
Outcomes
Primary Outcome Measures
Detection of tumor necrosis post-chemotherapy
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 Outcome Measures
Maximum Standardized Uptake Value (SUVmax)
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. Based on the PET/CT scans, the maximum standardized uptake value (SUVmax) in the tumor region of interest (ROI) will be calculated at baseline and after treatment. The outcome will be reported as the mean percent change in SUVmax from baseline to post treatment, with standard deviation.
Use of Patient Reported Outcomes Measurement Information System (PROMIS) to Assess Treatment Effect
Participants will receive neoadjuvant (pre surgery) chemotherapy, nominally three 3 week cycles administered over up to 12 weeks. The treatment effect of the neoadjuvant chemotherapy will be assessed as the change in scores on the PROMIS (Patient Reported Outcomes Measurement Information System) questionnaire, from baseline to post treatment. The result will be reported as the mean difference from baseline to post treatment, with standard deviation.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04365660
Brief Title
18F-FTC-146 PET/CT in Newly-Diagnosed Osteosarcoma
Official Title
A Phase 2 Study of 18F FTC 146 PET/CT in Patients With Newly Diagnosed Osteosarcoma
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 28, 2021 (Actual)
Primary Completion Date
January 2023 (Anticipated)
Study Completion Date
July 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteosarcoma
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
18-F-FTC 146 PET/CT
Arm Type
Experimental
Arm Description
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 Type
Drug
Intervention Name(s)
18-F FTC 146
Intervention Description
Radiotracer, 10 mCi at pre- and post- chemotherapy, intravenous administration
Primary Outcome Measure Information:
Title
Detection of tumor necrosis post-chemotherapy
Description
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.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Maximum Standardized Uptake Value (SUVmax)
Description
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. Based on the PET/CT scans, the maximum standardized uptake value (SUVmax) in the tumor region of interest (ROI) will be calculated at baseline and after treatment. The outcome will be reported as the mean percent change in SUVmax from baseline to post treatment, with standard deviation.
Time Frame
12 weeks
Title
Use of Patient Reported Outcomes Measurement Information System (PROMIS) to Assess Treatment Effect
Description
Participants will receive neoadjuvant (pre surgery) chemotherapy, nominally three 3 week cycles administered over up to 12 weeks. The treatment effect of the neoadjuvant chemotherapy will be assessed as the change in scores on the PROMIS (Patient Reported Outcomes Measurement Information System) questionnaire, from baseline to post treatment. The result will be reported as the mean difference from baseline to post treatment, with standard deviation.
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with biopsy proven osteosarcoma requiring local surgical intervention.
ECOG ≤ 2
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 146.
Pregnant or nursing
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kristen N Ganjoo
Organizational Affiliation
Stanford Universiy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University
City
Stanford
State/Province
California
ZIP/Postal Code
94304
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
18F-FTC-146 PET/CT in Newly-Diagnosed Osteosarcoma
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