Imaging With a PET Agent for Detection of Cancers of the Head and Neck

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.

This is an open label, investigator initiated single arm, first in human study of a PARP1/2 imaging agent in patients with head and neck squamous cell carcinomas scheduled to undergo surgery.

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.

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.

Patients will be injected with approximately 10 mCi of [18F]PARPi and a dynamic PET scan of will be acquired for approximately 30 minutes. A second body PET/CT scan will be started approximately 60 min post injection, and a third PET/CT scan will be started at approximately 120 min post injection. The first (dynamic) and the second (body) PET/CT scan will use "ultra -low dose" CT scan for attenuation correction. The last PET/CT scan will be performed with the investigator's regular clinical low-dose CT settings.

Inclusion Criteria: Part 1: 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 Part 2 Age ≥18 years ECOG performance status 0 or 1 Biopsy (histologically or cytologically) proven Squamous Cell Carcinoma Oral cavity,oropharynx, or nasopharynx primary site Scheduled to undergo surgery (neck dissection and/ or neck dissection + surgical removal of the primary) at MSK Willingness to sign informed consent Should have had a standard-of-care [18F]-FDG PET/CT scan before surgery (to minimize the possibility of new alterations developing between the two scans both scans should be acquired within a maximum time difference of one month). Exclusion Criteria: Significantly impaired organ function that may interfere with the excretion and metabolism of the imaging agent. Specifically, patients will be excluded if they meet the following criteria: Hematologic o Platelets <75K/mcL Hepatic Bilirubin >2.0 x ULN (institutional upper limits of normal) AST/ALT >2.5 x ULN Renal o Creatinine > 2.0 x ULN Claustrophobia interfering with PET/CT imaging Known allergy to PEG300 Pregnancy or breastfeeding