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

NCT04365660 | Terminated Phase 2 Results DMC FDA Drug

• 3 other identifiers: IRB-52746SARCOMA0041NCI-2021-03443
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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").

Conditions

Osteosarcoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Maximum Standardized Uptake Value (SUVmax)

  12 weeks

• Use of Patient Reported Outcomes Measurement Information System (PROMIS) to Assess Treatment Effect

  12 weeks

Study Arms (1)

18-F-FTC 146 PET/CT

EXPERIMENTAL

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).

Drug: 18-F FTC 146

Interventions

18-F FTC 146 DRUG

Radiotracer, 10 mCi at pre- and post- chemotherapy, intravenous administration

18-F-FTC 146 PET/CT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with biopsy proven osteosarcoma requiring local surgical intervention.
• ECOG ≤ 2
• Ability to understand and the willingness to sign a written informed consent document.

You may not qualify if:

• Chemotherapy in the past 2 months.
• Prior history of allergic reaction to 18F FTC 146.
• Pregnant or nursing

Sponsors & Collaborators

• Davidzon, Guido, M.D.: lead

Study Sites (1)

Stanford University

Stanford, California, 94304, United States

Location

MeSH Terms

Conditions

Osteosarcoma

Condition Hierarchy (Ancestors)

Neoplasms, Bone Tissue; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Sarcoma

Results Point of Contact

• Title: Dr. Kristen Ganjoo, MD
• Organization: Stanford University

kganjoo@stanford.edu

650-498-6000

Study Officials

• Kristen N Ganjoo

  Stanford Universiy

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine (Oncology)

Study Record Dates

• First Submitted: April 24, 2020
• First Posted: April 28, 2020
• Study Start: January 28, 2021
• Primary Completion: May 28, 2021
• Study Completion: July 22, 2021
• Last Updated: November 14, 2023
• Results First Posted: November 14, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)