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

Memorial Sloan Kettering Cancer Center (MSK) logo

Memorial Sloan Kettering Cancer Center (MSK)

Status and phase

Enrolling
Phase 2
Phase 1

Conditions

Head and Neck Cancer

Treatments

Drug: [18F]- PARPi
Diagnostic Test: PET/CT Scans

Study type

Interventional

Funder types

Other

Identifiers

NCT03631017
18-247

Details and patient eligibility

About

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.

Enrollment

27 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Diagnostic

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

27 participants in 2 patient groups

Phase I: [18 F]-PARPi and PET/CT Scans
Experimental group
Description:
The intervention of this study is the injection of a microdose (< 10 0 ug) of [18 F]- PARPi followed by 3 PET/CT studies to determine the biodistribution of this imaging agent in normal organs as well as the kinetics of uptake in squamous cell carcinomas of the head and neck.
Treatment:
Diagnostic Test: PET/CT Scans
Drug: [18F]- PARPi
Phase II: [18 F]-PARPi and PET/CT Scans
Experimental group
Description:
The intervention of this study is the injection of a microdose (< 10 0 ug) of [18 F]- PARPi followed by 3 PET/CT studies to determine the biodistribution of this imaging agent in normal organs as well as the kinetics of uptake in squamous cell carcinomas of the head and neck.
Treatment:
Diagnostic Test: PET/CT Scans
Drug: [18F]- PARPi

Trial contacts and locations

1

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Central trial contact

Heiko Schöder, MD; Ravinder Grewal, MD

Data sourced from clinicaltrials.gov

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