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

NCT03631017 | Active Not Recruiting Phase 1 FDA Drug

• 1 other identifier: 18-247
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Head and Neck Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• severity of adverse events

  according to Common Terminology Criteria for Adverse Events (CTCAE 4.0).

  2 years

Study Arms (2)

Phase I: [18 F]-PARPi and PET/CT Scans

EXPERIMENTAL

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.

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

Phase II: [18 F]-PARPi and PET/CT Scans

EXPERIMENTAL

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.

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

Interventions

[18F]- PARPi DRUG

injection of a microdose (\< 100 ug) of \[18F\]- PARPi

Phase I: [18 F]-PARPi and PET/CT Scans; Phase II: [18 F]-PARPi and PET/CT Scans

PET/CT Scans DIAGNOSTIC_TEST

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.

Phase I: [18 F]-PARPi and PET/CT Scans; Phase II: [18 F]-PARPi and PET/CT Scans

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead

Study Sites (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

Positron Emission Tomography Computed Tomography

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Positron-Emission Tomography; Tomography, Emission-Computed; Image Interpretation, Computer-Assisted; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Tomography, X-Ray Computed; Multimodal Imaging; Radiographic Image Enhancement; Image Enhancement; Photography; Radiography; Tomography, X-Ray; Radionuclide Imaging; Tomography; Diagnostic Techniques, Radioisotope

Study Officials

• Heiko Schöder, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is an open label, investigator initiated single arm, first in human study of a PARP1/2 imaging agent in patients with head and neck squamous cell carcinomas scheduled to undergo surgery.

Study Record Dates

• First Submitted: August 11, 2018
• First Posted: August 15, 2018
• Study Start: August 10, 2018
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: September 3, 2025

Record last verified: 2025-09

Locations

US (1)