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

Phase 1

Recruiting

• Conditions: Head and Neck Cancer
• Interventions: Drug: [18F]- PARPi; Diagnostic Test: PET/CT Scans

• Registration Number: NCT03631017
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2018-08-10
• Study First Submitted: 2018-08-11
• Study First Submitted QC: 2018-08-14
• Study First Posted: 2018-08-15
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-09
• Last Update Posted: 2024-01-10
• Primary Completion: 2025-08
• Study Completion: 2025-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 27

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).

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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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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Phase I: [18 F]-PARPi and PET/CT Scans	[18F]- PARPi	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.
Phase I: [18 F]-PARPi and PET/CT Scans	PET/CT Scans	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.
Phase II: [18 F]-PARPi and PET/CT Scans	[18F]- PARPi	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.
Phase II: [18 F]-PARPi and PET/CT Scans	PET/CT Scans	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.

Primary Outcome Measures

Name	Time	Method
severity of adverse events	2 years	according to Common Terminology Criteria for Adverse Events (CTCAE 4.0).

Trial Locations

Locations (1)

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States