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

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)

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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