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

Purpose

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.

Condition	Intervention
Head and Neck Cancer	Other: F-MISO PET scan

Study Type:	Interventional
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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Head and Neck Cancer Nuclear Scans Oxygen Therapy

Drug Information available for: Fluorine Fluoride

U.S. FDA Resources

Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	150
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)

Arms	Assigned Interventions
Experimental: 1 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.	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 30 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. Other Names: 5-10 days into your chemoradiation treatment you might have a repeat FMISO PET scan session depending on the results of your first scan. This scan will be used to see whether there is a reduction within the volume of your tumor. In order to inject the hypoxia tracer FMISO, an intravenous line will be necessary. The injection of the FMISO tracer will only occur before the first scan. During the FMISO PET scan, a maximum of eight small blood samples will be drawn at times determined by your radiologist. The entire process will take about three to four hours. These scans will be performed in the same manner as described above.

Arms

Assigned Interventions

Experimental: 1

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.

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 30 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.

Other Names:

5-10 days into your chemoradiation treatment you might have a repeat FMISO PET
scan session depending on the results of your first scan. This scan will be used to see whether there is a reduction within the
volume of your tumor. In order to inject the hypoxia tracer FMISO,
an intravenous line will be necessary. The injection of the FMISO tracer will
only occur before the first scan. During the FMISO PET scan, a maximum of
eight small blood samples will be drawn at times determined by your radiologist. The entire process will take about three to four hours.
These scans will be performed in the same manner as described above.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Histologically confirmed diagnosis of head and neck carcinoma (excluding nasopharynx, paranasal sinus, salivary, and thyroid malignancies)Any unknown primary squamous cell carcinoma of head and neck with gross nodes is allowed (2002 AJCC)
18 years of age or older
Must not have received prior radiation therapy or chemotherapy for this diagnosis. Patients who have had their primary site tumor removed by surgery but still present with grossly enlarged lymph nodes are eligible for this study.
Karnofsky performance status ≥ 70.

Exclusion Criteria:

all nasopharyngeal, paranasal sinus, salivary cancer, and thyroid malignancies
prior chemotherapy or radiotherapy within the last three years
patients that underwent surgical resection for the same disease (except for biopsy or surgery removing primary site tumor but still present with grossly enlarged lymph nodes)
any prior radiotherapy to the head and neck region
pregnant (confirmed by serum b-HCG in women of reproductive age) or breast feeding

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00606294

Contacts

Contact: Nancy Lee, MD	212-639-3341
Contact: Heiko Schoder, MD	212-639-2079

Locations

United States, New York
Memorial Sloan Kettering Cancer Center	Recruiting
New York, New York, United States, 10065
Contact: Nancy Lee, MD 212-639-3341

Sponsors and Collaborators

Memorial Sloan-Kettering Cancer Center

Investigators

Principal Investigator:

Nancy Lee, MD

Memorial Sloan-Kettering Cancer Center

More Information

Additional Information:

Memorial Sloan-Kettering Cancer Center This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:	NCT00606294 History of Changes
Other Study ID Numbers:	04-070
Study First Received:	January 10, 2008
Last Updated:	April 2, 2013
Health Authority:	United States: Institutional Review Board

Keywords provided by Memorial Sloan-Kettering Cancer Center:

Head
Neck
04-070

Additional relevant MeSH terms:

Head and Neck Neoplasms
Anoxia
Neoplasms by Site
Neoplasms
Signs and Symptoms, Respiratory
Signs and Symptoms
Fluorides
Misonidazole
Fluoromisonidazole
Cariostatic Agents

Protective Agents
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on June 17, 2013