Safety, Biodistribution and Radiation Dosimetry of [18F]PARPi

Status: Active, not recruiting
Location: See location...
Intervention Type: Diagnostic Test, Drug
Study Type: Interventional
Study Phase: Phase 1

The purpose of this study is to test the safety of a study drug called PARPi-FL. This drug has been tested in animals but not yet in people. The purpose of this study is to test if a PARPi-FL scan can be used to take pictures of head and neck cancer. The usual approach to imaging this cancer includes several different imaging scans, including x-rays, CT (computed tomography), MRI (magnetic resonance imaging), and PET (positron emission tomography). These tests take pictures of the cancer.

Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: No

• Age ≥18 years

• ECOG performance status 0 or 1

• Biopsy (histologically or cytologically) proven Squamos Cell Carcinoma

• Oral cavity, oropharynx, or nasopharynx primary site

• At least one tumor lesion on standard of care imaging with a minimum diameter of at least 1.5 cm

• Scheduled to undergo treatment at MSKCC

• Willingness to sign informed consent

United States
New York
Memorial Sloan Kettering Cancer Center
New York
Time Frame
Start Date: August 10, 2018
Estimated Completion Date: August 2023
Target number of participants: 12
Experimental: [18 F]-PARPi and PET/CT Scans
The intervention of this study is the injection of a microdose (< 10 0 ug) of [18 F]- PARPi followed by 3 PET/CT studies to determine the biodistribution of this imaging agent in normal organs as well as the kinetics of uptake in squamous cell carcinomas of the head and neck.
Leads: Memorial Sloan Kettering Cancer Center

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