Overview

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

Status:
Active, not recruiting
Trial end date:
2022-08-01
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Criteria
Inclusion Criteria:

- 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

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