Using Fluorine-18-Labeled Fluoro-Misonidazole Positron Emission Tomography To Detect Hypoxia in Head and Neck Cancer Patients

Not Applicable

Completed

• Conditions: Head and Neck Cancer

• Registration Number: NCT00606294
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

Brief Summary

The main purpose of this study is to evaluate low oxygen areas called hypoxia within tumors. These low oxygen areas are thought to be the reason why tumors are more resistant to chemotherapy and radiation treatment.

An imaging technique using a hypoxia tracer called fluoromisonidazole (FMISO) can detect low oxygen areas within a tumor. This imaging technique, called a PET scan, uses positively charged particles to detect slight changes in the body's biochemistry and metabolism. FMISO PET scans have been performed in patients with head and neck cancer and have shown the ability to detect low oxygen areas within tumors.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-06
• Study First Submitted: 2008-01-10
• Study First Submitted QC: 2008-01-21
• Study First Posted: 2008-02-01
• Primary Completion: 2019-08
• Results First Submitted: 2020-06-09
• Results First Submitted QC: 2020-06-26
• Results First Posted: 2020-07-10
• Status Verified: 2023-06
• Study Completion: 2023-06-09
• Last Update Submitted: 2023-06-12
• Last Update Posted: 2023-06-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 216

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
To Determine the Pathologic Complete Response of Low Risk HPV+ Oropharyngeal Cancer Patients Without Hypoxia on 18F-FMISO PET Who Received 30Gy	4 months	For Cohort 2 - Feasibility will be determined by the pathologic response rate at time of neck dissection
Improve the Accuracy of Hypoxia Imaging for Head and Neck Cancers Through Pixel by Pixel Kinetic Analysis of 18F-FMISO Tracer of Dynamic PET Images	At baseline	Cohort 2
To Report Positive Versus Negative Hypoxia Among Head and Neck Cancers Using 18F-FMISO Dynamic PET	4 months	For Cohort 1

Secondary Outcome Measures

Name	Time	Method
To Detect on Repeat 18F-FMISO PET/CT Scans Whether There is a Reduction of the FMISO-avid or GTVh 5 to 10 Days Into Treatment With Standard Chemoradiotherapy for a Series of Locally Advanced Head and Neck Cancers.	2 weeks from time of scan	For Cohort 1

Trial Locations

Locations (5)

Memorial Sloan Kettering Cancer Center at Basking Ridge; 🇺🇸 Basking Ridge, New Jersey, United States

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

Memorial Sloan Kettering Westchester; 🇺🇸 Harrison, New York, United States

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

Memorial Sloan Kettering Cancer Center at Mercy Medical Center; 🇺🇸 Rockville Centre, New York, United States