CompletedEarly Phase 1

Fluciclovine F18 PET/CT in Identifying the Origin of Head and Neck Squamous Cell Carcinoma in Patients With Metastatic Cervical Nodal Disease

United States16 participantsStarted 2019-04-24

Plain-language summary

This early phase I trial studies how well fluciclovine F18 positron emission tomography (PET)/computed tomography (CT) works in identifying the origin of head and neck squamous cell carcinoma in patients with cancer that has spread to the cervical lymph nodes. Fluciclovine F18 during a PET/CT scan may work better in helping doctors learn where the cancer started (called the site of origin) and directing treatment planning compared to standard fludeoxyglucose F-18 (FDG) PET-CT scans.

Who can participate

Age range18 Years

SexALL

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Inclusion Criteria: * Adults with biopsy proven metastatic cervical nodal squamous cell carcinoma * CT of the neck with contrast that does not confidently identify a primary oropharyngeal site of disease * Planned standard of care 18F-FDG PET CT examination * Planned standard of care exam under anesthesia with oropharyngeal surgical biopsy Exclusion Criteria: * Pregnant women * Known allergy to FDG, fluciclovine, or iodine-based contrast agents * Severe renal dysfunction (glomerular filtrate rate \[within 30 days\] less than 30) * Inability to tolerate lying supine, relatively motionless for up to 1 hour

What they're measuring

Proportion of the suspected lesions that are positive by the gold standard of pathology

Timeframe: Up to 2 years

Trial details

NCT IDNCT03868020

SponsorM.D. Anderson Cancer Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-03-22

View on ClinicalTrials.gov More Metastatic Head and Neck Squamous Cell Carcinoma trials