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fluorine-18-labeled fluoro-misonidazole (18F-FMISO) for Head and Neck Cancers

N/A

Waitlist Available

Led By Nancy Lee, MD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 months

Awards & highlights

Study Summary

This trial will test whether or not the addition of the FMISO PET scan can help doctors better plan treatment for patients with head and neck cancer.

Eligible Conditions

Head and Neck Cancer

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

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

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

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.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Cohort 2 (closed to accrual)Experimental Treatment4 Interventions

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.

Group II: Cohort 1 (closed to accrual)Experimental Treatment4 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

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

2004

N/A

~220

18F-FMISO PET scan

2004

N/A

~220

MRI

2009

Completed Phase 2

~1370

FDG PET/CT scan

2004

Completed Phase 2

~250

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor

1,935 Previous Clinical Trials

588,639 Total Patients Enrolled

Nancy Lee, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center

12 Previous Clinical Trials

1,882 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any vacancies left for volunteers in this clinical trial?

"As listed on clinicaltrials.gov, this trial is not accepting applicants presently. Initially posted on June 1st, 2004 and last updated July 8th 2022, the study has concluded its recruitment process; however, there are 636 other studies still recruiting patients."

Answered by AI

Are there any limitations on where this investigation is being conducted?

"Memorial Sloan Kettering Cancer Center at Commack, Memorial Sloan Kettering Westchester in Harrison, and Memorial Sloan Kettering Cancer Center at Basking Ridge are the only three of five total sites now engaged in this trial."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2004. "Using Fluorine-18-Labeled Fluoro-Misonidazole Positron Emission Tomography To Detect Hypoxia in Head and Neck Cancer Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00606294.