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Active, Not Recruiting

NCT Number: NCT03631017

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Memorial Sloan Kettering Cancer Center

New York, 10065, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

[18F]- PARPi

Drug

injection of a microdose (< 100 ug) of [18F]- PARPi

PET/CT Scans

Diagnostic Test

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.

Primary outcomes

  1. severity of adverse events

    Time frame: 2 years

    according to Common Terminology Criteria for Adverse Events (CTCAE 4.0).

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2026
Study completion
2026
First posted
Aug 15, 2018
Registry last updated
Sep 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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