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

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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

Tracking Information
First Submitted Date  ICMJE January 10, 2008
First Posted Date  ICMJE February 1, 2008
Results First Submitted Date  ICMJE June 9, 2020
Results First Posted Date  ICMJE July 10, 2020
Last Update Posted Date July 10, 2020
Actual Study Start Date  ICMJE June 2004
Actual Primary Completion Date August 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 26, 2020)
  • To Report Positive Versus Negative Hypoxia Among Head and Neck Cancers Using 18F-FMISO Dynamic PET [ Time Frame: 4 months ]
    For Cohort 1
  • 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
  • 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
Original Primary Outcome Measures  ICMJE
 (submitted: January 21, 2008)
Perform FDG PET/CT w/immobilization devices used during radiotherapy simulation. Perform a pre-treatmnt dynamic 18F-MISO PET to verify constancy of hypoxic regions w/in gross tumor volume (GTVh). The scan will occur after FDG PET/CT, prior to initiatin [ Time Frame: 5 years ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 16, 2020)
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
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Using Fluorine-18-Labeled Fluoro-Misonidazole Positron Emission Tomography To Detect Hypoxia in Head and Neck Cancer Patients
Official Title  ICMJE A Study Using Fluorine-18-Labeled Fluoro-Misonidazole Positron Emission Tomography To Detect Hypoxia in Head and Neck Cancer Patients
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Head and Neck Cancer
Intervention  ICMJE
  • Radiation: fluorine-18-labeled fluoro-misonidazole (18F-FMISO)
  • Device: 18F-FMISO PET scan
  • Device: MRI
  • Device: FDG PET/CT scan
Study Arms  ICMJE
  • 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.
    Interventions:
    • 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.
    Interventions:
    • Radiation: fluorine-18-labeled fluoro-misonidazole (18F-FMISO)
    • Device: 18F-FMISO PET scan
    • Device: MRI
    • Device: FDG PET/CT scan
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: June 26, 2020)
216
Original Estimated Enrollment  ICMJE
 (submitted: January 21, 2008)
40
Estimated Study Completion Date  ICMJE June 2021
Actual Primary Completion Date August 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00606294
Other Study ID Numbers  ICMJE 04-070
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Memorial Sloan Kettering Cancer Center
Study Sponsor  ICMJE Memorial Sloan Kettering Cancer Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Nancy Lee, MD Memorial Sloan Kettering Cancer Center
PRS Account Memorial Sloan Kettering Cancer Center
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP