Head and Neck Cancer
Conditions
Keywords
Radiation Dosimetry of [18F]PARPi, PET/CT scans
Brief 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.
Interventions
DRUG[18F]- PARPi
injection of a microdose (\< 100 ug) of \[18F\]- PARPi
DIAGNOSTIC_TESTPET/CT Scans
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.
Sponsors
Memorial Sloan Kettering Cancer Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| severity of adverse events | 2 years | according to Common Terminology Criteria for Adverse Events (CTCAE 4.0). |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORHeiko Schöder, MD
Memorial Sloan Kettering Cancer Center
Outcome results
None listed