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Clinical Trials/NCT00606294
NCT00606294
Completed
Not Applicable

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

Memorial Sloan Kettering Cancer Center5 sites in 1 country216 target enrollmentJune 2004

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Head and Neck Cancer
Sponsor
Memorial Sloan Kettering Cancer Center
Enrollment
216
Locations
5
Primary Endpoint
To Report Positive Versus Negative Hypoxia Among Head and Neck Cancers Using 18F-FMISO Dynamic PET
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 2004
End Date
June 9, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

To Report Positive Versus Negative Hypoxia Among Head and Neck Cancers Using 18F-FMISO Dynamic PET

Time Frame: 4 months

For Cohort 1

To Determine the Pathologic Complete Response of Low Risk HPV+ Oropharyngeal Cancer Patients Without Hypoxia on 18F-FMISO PET Who Received 30Gy

Time Frame: 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

Time Frame: At baseline

Cohort 2

Secondary Outcomes

  • 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)

Study Sites (5)

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