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

Study Overview
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Brief Summary
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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.

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

Conditions
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Head and Neck Cancer

Intervention / Treatment
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* Drug: [18F]- PARPi
* Diagnostic Test: PET/CT Scans


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Phase I: [18 F]-PARPi and PET/CT Scans<br>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. | Drug: [18F]- PARPi<br>* injection of a microdose (< 100 ug) of [18F]- PARPi<br>Diagnostic Test: PET/CT Scans<br>* 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.<br>|
| Experimental: Phase II: [18 F]-PARPi and PET/CT Scans<br>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. | Drug: [18F]- PARPi<br>* injection of a microdose (< 100 ug) of [18F]- PARPi<br>Diagnostic Test: PET/CT Scans<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| severity of adverse events | according to Common Terminology Criteria for Adverse Events (CTCAE 4.0). | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Radiation Dosimetry of [18F]PARPi, PET/CT scans