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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00606294
Recruitment Status : Active, not recruiting
First Posted : February 1, 2008
Results First Posted : July 10, 2020
Last Update Posted : July 10, 2020
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Study Description
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Brief Summary:

The main 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.

An 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 or disease Intervention/treatment Phase
Head and Neck Cancer Radiation: fluorine-18-labeled fluoro-misonidazole (18F-FMISO) Device: 18F-FMISO PET scan Device: MRI Device: FDG PET/CT scan Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 216 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Actual Study Start Date : June 2004
Actual Primary Completion Date : August 2019
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Fluorine

Arms and Interventions
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Arm Intervention/treatment
Experimental: Cohort 1 (closed to accrual)
Cohort 1 (closed to accrual) Cohort 1 (closed to accrual) 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. This is currently one accepted standard of care. In a subcohort of 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 treatment 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 (closed to accrual)
Experimental: Cohort 2 (closed to accrual) Cohort 2 HPV+ tumors that demonstrate no evidence of hypoxia on an 18F-FMISO PET scan will receive 30Gy to the surgical bed and neck lymph nodes concurrent with standard chemotherapy followed by a 3-4 month post-treatment neck dissection. In patients who exhibit a complete response with this method of treatment, no further treatment is necessary. For patients within this select group who still have pathologic nodal disease, further standard chemoradiation will be given. All other patients in this cohort (i.e. those who are not in the select HPV+ tumor group outlined above) will receive standard of care treatment following their surgery.
 Radiation: fluorine-18-labeled fluoro-misonidazole (18F-FMISO)
Device: 18F-FMISO PET scan
Device: MRI
Device: FDG PET/CT scan


Outcome Measures
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Primary Outcome Measures :
  1. To Report Positive Versus Negative Hypoxia Among Head and Neck Cancers Using 18F-FMISO Dynamic PET [ Time Frame: 4 months ]
    For Cohort 1

  2. To Determine the Pathologic Complete Response of Low Risk HPV+ Oropharyngeal Cancer Patients Without Hypoxia on 18F-FMISO PET Who Received 30Gy [ Time Frame: 4 months ]
    For Cohort 2 - Feasibility will be determined by the pathologic response rate at time of neck dissection

  3. 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: At baseline ]
    Cohort 2


Secondary Outcome Measures :
  1. 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: 2 weeks from time of scan ]
    For Cohort 1


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

• 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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00606294


Locations
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United States, New Jersey
Memorial Sloan Kettering Cancer Center at Basking Ridge
Basking Ridge, New Jersey, United States
United States, New York
Memorial Sloan Kettering Cancer Center at Commack
Commack, New York, United States, 11725
Memorial Sloan Kettering Westchester
Harrison, New York, United States, 10604
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Memorial Sloan Kettering Cancer Center at Mercy Medical Center
Rockville Centre, New York, United States, 11570
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Investigators
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Principal Investigator: Nancy Lee, MD Memorial Sloan Kettering Cancer Center
  Study Documents (Full-Text)

Documents provided by Memorial Sloan Kettering Cancer Center:
Study Protocol and Statistical Analysis Plan  [PDF] April 1, 2020

More Information
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Additional Information:

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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00606294    
Other Study ID Numbers: 04-070
First Posted: February 1, 2008    Key Record Dates
Results First Posted: July 10, 2020
Last Update Posted: July 10, 2020
Last Verified: June 2020
Keywords provided by Memorial Sloan Kettering Cancer Center:
Head
Neck
04-070
Additional relevant MeSH terms:
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Head and Neck Neoplasms
Hypoxia
Neoplasms by Site
Neoplasms
Signs and Symptoms, Respiratory
 Misonidazole
Antineoplastic Agents
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents