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

Osteosarcoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04365660
• Other study ID #: IRB-52746
• Secondary ID: SARCOMA0041IRB-5
• Status: Terminated
• Phase: Phase 2
• Start date: January 28, 2021
• Est. completion date: July 22, 2021

Study information

• Verified date: October 2023
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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").

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: July 22, 2021
• Est. primary completion date: May 28, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Osteosarcoma

Intervention

Drug:
• 18-F FTC 146
Radiotracer, 10 mCi at pre- and post- chemotherapy, intravenous administration

Locations

Country	Name	City	State
United States	Stanford University	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Davidzon, Guido, M.D.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	12 weeks
Secondary	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.	12 weeks
Secondary	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.	12 weeks