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

Sponsored by:	Memorial Sloan-Kettering Cancer Center
Information provided by:	Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:	NCT00606294

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:	Diagnostic, Open Label, Single Group Assignment, Efficacy Study
Official Title:	A Feasibility 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

Drug Information available for: Misonidazole

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:	70
Study Start Date:	June 2004
Estimated Study Completion Date:	June 2010
Estimated Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	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.

Arms

Assigned Interventions

1: Experimental

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.

Eligibility

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

Criteria

Inclusion Criteria:

provide written informed consent
histologically confirmed diagnosis of head and neck carcinoma (excluding nasopharynx, paranasal sinus, salivary, and thyroid malignancies) (2002 AJCC)
18 years of age or older
newly diagnosed head and neck carcinoma (excluding nasopharynx, paranasal sinus, salivary, and thyroid malignancies) must not have received prior radiation therapy or chemotherapy or surgery (except for biopsy) for this diagnosis
Karnofsky performance status ≥ 70.

Exclusion Criteria:

all nasopharyngeal, paranasal sinus, salivary cancer, and thyroid malignancies
Karnofsky performance status < 70
prior chemotherapy or radiotherapy within the last three years
patients that underwent surgical resection for the same disease (except for biopsy)
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		leen2@mskcc.org
Contact: Heiko Schoder, MD		schoderh@mskcc.org

Locations

United States, New York
Memorial Sloan Kettering Cancer Center	Recruiting
New York, New York, United States, 10065

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 ( Lee, Nancy, MD / Principal Investigator )
Study ID Numbers:	04-070
Study First Received:	January 10, 2008
Last Updated:	June 30, 2009
ClinicalTrials.gov Identifier:	NCT00606294 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Memorial Sloan-Kettering Cancer Center:

Head
Neck

Study placed in the following topic categories:

Anti-Infective Agents
Radiation-Sensitizing Agents
Ro 07-0741

Head and Neck Neoplasms
Misonidazole
Fluorides

Additional relevant MeSH terms:

Anti-Infective Agents
Antiprotozoal Agents
Antineoplastic Agents
Ro 07-0741
Physiological Effects of Drugs
Pharmacologic Actions
Neoplasms

Antiparasitic Agents
Neoplasms by Site
Radiation-Sensitizing Agents
Head and Neck Neoplasms
Therapeutic Uses
Misonidazole

ClinicalTrials.gov processed this record on September 03, 2009