Clinical Trial · NCT03868020

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

Overview

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.

Sponsor

MD Anderson Cancer Center

Phase

Early Phase 1

Contacts

Maria K Gule-Monroe (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT03868020

Drug / Compound

Fluciclovine

Isotope(s):

Target(s):

Amino Acid Transport

Ligand Class: Small Molecules

Eligibility

Inclusion

CT of the neck with contrast that does not confidently identify a primary oropharyngeal site of disease
Planned standard of care exam under anesthesia with oropharyngeal surgical biopsy
Planned standard of care 18F-FDG PET CT examination
Adults with biopsy proven metastatic cervical nodal squamous cell carcinoma

Exclusion

Inability to tolerate lying supine, relatively motionless for up to 1 hour
Severe renal dysfunction (glomerular filtrate rate \[within 30 days\] less than 30)
Known allergy to FDG, fluciclovine, or iodine-based contrast agents