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

Sponsor: Memorial Sloan Kettering Cancer Center

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT03631017

Provider View

This study evaluates the safety of PARPi-FL for imaging head and neck cancer. Eligible participants are adults with confirmed squamous cell carcinoma, meeting specific health criteria. The intervention involves injecting a microdose of \[18F\]-PARPi, followed by a series of PET/CT scans to assess imaging efficacy. Exclusion criteria include impaired organ function and pregnancy.

Patient Parameters

Program Overview

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.

Eligibility Criteria

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

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