ACTIVE_NOT_RECRUITING

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

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Conditions

Head and Neck CancerRadiation Dosimetry of [18F]PARPiPET/CT scans

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

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

Quick Facts

Study Start:2018-08-10
Study Completion:2026-08
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT03631017

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age ≥18 years
  2. * ECOG performance status 0 or 1
  3. * Biopsy (histologically or cytologically) proven Squamos Cell Carcinoma
  4. * Oral cavity, oropharynx, or nasopharynx primary site
  5. * At least one tumor lesion on standard of care imaging with a minimum diameter of at least 1.5 cm
  6. * Scheduled to undergo treatment at MSKCC
  7. * Willingness to sign informed consent
  8. * Age ≥18 years
  9. * ECOG performance status 0 or 1
  10. * Biopsy (histologically or cytologically) proven Squamous Cell Carcinoma
  11. * Oral cavity,oropharynx, or nasopharynx primary site
  12. * Scheduled to undergo surgery (neck dissection and/ or neck dissection + surgical removal of the primary) at MSK
  13. * Willingness to sign informed consent
  14. * 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).
  1. * 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:
  2. * Hematologic
  3. * Hepatic
  4. * Bilirubin \>2.0 x ULN (institutional upper limits of normal)
  5. * AST/ALT \>2.5 x ULN
  6. * Renal
  7. * Claustrophobia interfering with PET/CT imaging
  8. * Known allergy to PEG300
  9. * Pregnancy or breastfeeding

Contacts and Locations

Principal Investigator

Heiko Schöder, MD
PRINCIPAL_INVESTIGATOR
Memorial Sloan Kettering Cancer Center

Study Locations (Sites)

Memorial Sloan Kettering Cancer Center
New York, New York, 10065
United States

Collaborators and Investigators

Sponsor: Memorial Sloan Kettering Cancer Center

  • Heiko Schöder, MD, PRINCIPAL_INVESTIGATOR, Memorial Sloan Kettering Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2018-08-10
Study Completion Date2026-08

Study Record Updates

Study Start Date2018-08-10
Study Completion Date2026-08

Terms related to this study

Keywords Provided by Researchers

  • Radiation Dosimetry of [18F]PARPi
  • PET/CT scans

Additional Relevant MeSH Terms

  • Head and Neck Cancer