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

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

1 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-28

Study Completion Date

2021-07-22

Brief Summary

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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").

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Detailed Description

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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.

Conditions

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Osteosarcoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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).

Group Type EXPERIMENTAL

18-F FTC 146

Intervention Type DRUG

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

Interventions

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18-F FTC 146

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

Intervention Type DRUG

Eligibility Criteria

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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.