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

Davidzon, Guido, M.D.

Status and phase: Terminated; Phase 2

Conditions: Osteosarcoma

Treatments: Drug: 18-F FTC 146

Study type: Interventional

Funder types: Other

Identifiers

NCT04365660

IRB-52746 (Other Identifier)

NCI-2021-03443 (Registry Identifier)

SARCOMA0041 (Other Identifier)

Details and patient eligibility

About

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").

Full 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.

Enrollment: 1 patient

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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1 participants in 1 patient group

18-F-FTC 146 PET/CT

Experimental group

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).

Treatment:

Drug: 18-F FTC 146