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

Head and Neck Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03631017
• Other study ID #: 18-247
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: August 10, 2018
• Est. completion date: August 2025

Study information

• Verified date: January 2024
• Source: Memorial Sloan Kettering Cancer Center
• Contact: Heiko Schöder, MD
• Phone: 212-639-2079
• Email: schoderh[@]mskcc.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 27
• Est. completion date: August 2025
• Est. primary completion date: August 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms

Intervention

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

Diagnostic Test:
• PET/CT Scans
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.

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Cancer Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	severity of adverse events	according to Common Terminology Criteria for Adverse Events (CTCAE 4.0).	2 years

External Links

•   Memorial Sloan Kettering Cancer Center