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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2015 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: April 21, 2015
Last verified: April 2015
  Purpose

The 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.

A recent 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.


Condition Intervention
Head and Neck Cancer
Radiation: fluorine-18-labeled fluoro-misonidazole (18F-FMISO)
Device: 18F-FMISO PET scan
Device: MRI
Device: FDG PET/CT scan

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel 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-FMISO tracer of dynamic PET images. [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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. [ 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: Cohort 1
There will be no change or intervention in a patient's treatment regime using chemoradiation where both the primary and the neck nodes receive 70Gy if the tumors are not associated with HPV or if there is no resolution of hypoxia on their repeat 18F-FMISO PET/CT scan. This is currently one accepted standard of care. Patients in Cohort 1 with tumors that are positive for HPV who exhibited no evidence of hypoxia on their baseline 18F-FMISO PET/CT scan or whose tumors have early resolution of hypoxia on their repeat early response 18F-FMISO PET/CT scan will undergo an alternative standard of care where the primary tumor site receives 70Gy while the neck nodes receive 60Gy followed by a planned FDG PET/CT scan and observation.
Radiation: fluorine-18-labeled fluoro-misonidazole (18F-FMISO) Device: 18F-FMISO PET scan Device: MRI Device: FDG PET/CT scan
Experimental: Cohort 2
For patients in Cohort 2, there will be no change or intervention in a patient's standard treatment regime based on research findings. This is similar to the HPV- patients in Cohort 1, in which there is no change or intervention that occurs based on research findings. Cohort 2 patients will not receive a repeat 18F-FMISO PET/CT scan, will not receive approximately weekly MRIs, and will not receive a post-treatment MRI at 3 months, 6 months, and 1 year post-treatment.
Radiation: fluorine-18-labeled fluoro-misonidazole (18F-FMISO) Device: 18F-FMISO PET scan Device: MRI Device: FDG PET/CT scan

  Eligibility

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

Inclusion Criteria for Cohort 1 and Cohort 2 :

  • 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 for Cohort 1 and Cohort 2:

  • all nasopharyngeal, paranasal sinus, salivary cancer, and thyroid malignancies
  • prior chemotherapy or radiotherapy within the last three years
  • patients that underwent previous 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

Subject Exclusion Criteria for Optional Contrast MRIs - Cohort 1 Only

• Subjects with a known contraindication to the standard MRI contrast agent (Gadavist, a gadolinium-based contrast agent) and/or a recent estimated glomerular filtration rate (eGFR) of 30 or less will be excluded from all DCE-MRIs, and will instead receive non-contrast MRIs at the DCE-MRI time points.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 Jersey
Memorial Sloan Kettering Cancer Center at Basking Ridge Recruiting
Basking Ridge, New Jersey, United States
Contact: Nancy Lee, MD    212-639-3341      
United States, New York
Memorial Sloan Kettering Cancer Center at Commack Recruiting
Commack, New York, United States, 11725
Contact: Nancy Lee, MD    212-639-3341      
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Nancy Lee, MD    212-639-3341      
Memorial Sloan Kettering Cancer Center at Mercy Medical Center Recruiting
Rockville Centre, New York, United States, 11570
Contact: Nancy Lee, MD    212-639-3341      
Memorial Sloan Kettering Cancer Center at Phelps Memorial Hospital Center Recruiting
Sleepy Hollow, New York, United States, 10591
Contact: Nancy Lee, MD    212-639-3341      
Memorial Sloan Kettering West Harrison Recruiting
West Harrison, New York, United States, 10604
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: April 21, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by Memorial Sloan Kettering Cancer Center:
Head
Neck
04-070

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms
Neoplasms by Site
Fluorides
Fluoromisonidazole
Misonidazole
Anti-Infective Agents
Antineoplastic Agents
Antiparasitic Agents
Antiprotozoal Agents
Cariostatic Agents
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 27, 2015