Using Fluorine-18-Labeled Fluoro-Misonidazole Positron Emission Tomography To Detect Hypoxia in Head and Neck Cancer Patients
The purpose of this study is to evaluate low oxygen areas called hypoxia within the tumor. These low oxygen areas are thought to be the reason why tumors are more resistant to chemotherapy and radiation treatments.
A recent imaging technique using a hypoxia tracer called Fluoromisonidazole (FMISO) can detect low oxygen areas within the tumor. This imaging technique, called a PET scan, uses positively charged particles to detect slight changes in the body biochemistry and metabolism. FMISO PET scans have been performed in patients with head and neck cancer and have shown the ability to detect these low oxygen areas within the tumor.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||A Study Using Fluorine-18-Labeled Fluoro-Misonidazole Positron Emission Tomography To Detect Hypoxia in Head and Neck Cancer Patients|
- To improve the accuracy of hypoxia imaging for head and neck cancers through pixel by pixel kinetic analysis of 18F-MISO tracer of dynamic PET images. [ Time Frame: 5 years ] [ Designated as safety issue: No ]
- To detect on repeat 18F-MISO 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. [ Time Frame: 5 years ] [ Designated as safety issue: No ]
|Study Start Date:||June 2004|
|Estimated Study Completion Date:||June 2016|
|Estimated Primary Completion Date:||June 2016 (Final data collection date for primary outcome measure)|
This is a study using fluorine-18-labeled fluoro-misonidazole (18F-MISO), a hypoxia tracer, to evaluate biodistribution/detection of tumor hypoxia in head and neck cancer patients. wWe will also obtain multiparametric MR scans consisting of conventional anatomical MRI (eg. T1, T2-weighted) and diffusionweighted MRI (DW-MRI) to assess changes in MR intensities and perfusion and diffusion of water molecules in tumor and irradiated normal structures during and after the course of fractionated external beam radiation therapy.
Other: F-MISO PET scan
You will have the standard pretreatment tests for your head and neck cancer, including an FDG PET scan. You will have to fast for 4-6 hours before this scan, but you can drink as much water as you like. Before your radiation therapy begins, you will have an FMISO PET scan (the scan using the new imaging technique). You will be scanned three times. The first scan will take about 45 minutes. At 90 minutes, you will have a 10 minute scan. At about 150-180 minutes, you will have another 10 minute scan. You will not remain on the scanning table for the whole time, but will be removed and returned for the three scans. The reason for three scans is because there is useful scientific information contained within the time course of the tracer in the body. You also will have pre-treatment research MRI.
|Contact: Nancy Lee, MD||212-639-3341|
|Contact: Heiko Schoder, MD||212-639-2079|
|United States, New York|
|Memorial Sloan Kettering Cancer Center||Recruiting|
|New York, New York, United States, 10065|
|Contact: Nancy Lee, MD 212-639-3341|
|Principal Investigator:||Nancy Lee, MD||Memorial Sloan-Kettering Cancer Center|