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

This study is currently recruiting participants.
Verified February 2014 by Memorial Sloan-Kettering Cancer Center
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00606294
First received: January 10, 2008
Last updated: February 10, 2014
Last verified: February 2014
  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:


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. 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.
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. A repeated research MRI scan will be performed one day after the
  • FMISO PET scan, during the 4th week of treatment, at the end of treatment and then approximately 3, 6, and
  • 12 months post treatment. 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:
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: February 10, 2014
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 April 17, 2014