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

NCT00606294 | Completed Results DMC

• 1 other identifier: 04-070
• Study Type: interventional
• Target: 216
• Locations: 1 country
• Sites: 5

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.

Conditions

Head and Neck Cancer

Keywords

Head; Neck; 04-070

Outcome Measures

Primary Outcomes (3)

• To Report Positive Versus Negative Hypoxia Among Head and Neck Cancers Using 18F-FMISO Dynamic PET

  For Cohort 1

  4 months

• To Determine the Pathologic Complete Response of Low Risk HPV+ Oropharyngeal Cancer Patients Without Hypoxia on 18F-FMISO PET Who Received 30Gy

  For Cohort 2 - Feasibility will be determined by the pathologic response rate at time of neck dissection

  4 months

• 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

  Cohort 2

  At baseline

Secondary Outcomes (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.

  2 weeks from time of scan

Study Arms (2)

Cohort 1 (closed to accrual)

EXPERIMENTAL

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

Cohort 2 (closed to accrual)

EXPERIMENTAL

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

Interventions

fluorine-18-labeled fluoro-misonidazole (18F-FMISO) RADIATION

Cohort 1 (closed to accrual); Cohort 2 (closed to accrual)

18F-FMISO PET scan DEVICE

Cohort 1 (closed to accrual); Cohort 2 (closed to accrual)

MRI DEVICE

Cohort 1 (closed to accrual); Cohort 2 (closed to accrual)

FDG PET/CT scan DEVICE

Cohort 1 (closed to accrual); Cohort 2 (closed to accrual)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• 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.

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead

Study Sites (5)

Memorial Sloan Kettering Cancer Center at Basking Ridge

Basking Ridge, New Jersey, United States

Location

Memorial Sloan Kettering Cancer Center at Commack

Commack, New York, 11725, United States

Location

Memorial Sloan Kettering Westchester

Harrison, New York, 10604, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Memorial Sloan Kettering Cancer Center at Mercy Medical Center

Rockville Centre, New York, 11570, United States

Location

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

fluoromisonidazole

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Results Point of Contact

• Title: Dr. Nancy Lee, MD
• Organization: Memorial Sloan Kettering Cancer Center

leen2@mskcc.org

212-639-3341

Study Officials

• Nancy Lee, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2008
• First Posted: February 1, 2008
• Study Start: June 1, 2004
• Primary Completion: August 1, 2019
• Study Completion: June 9, 2023
• Last Updated: June 28, 2023
• Results First Posted: July 10, 2020

Record last verified: 2023-06

Locations

US (5)