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

PRIMARY OBJECTIVES:

I. To estimate positive predictive value with a corresponding 95% confidence interval for
fluciclovine F18 (18F fluciclovine) positron emission tomography computed tomography (PET CT)
to detect a primary site of disease in patients presenting with cervical metastatic nodal
disease but a head and neck primary site not apparent on CT of the neck with contrast
(contrast enhanced-computed tomography, CE-CT).

SECONDARY OBJECTIVES:

I. To estimate positive predictive value with a corresponding 95% confidence interval for
fludeoxyglucose F-18 (18F FDG) PET CT in the detection of a primary site of disease in
patients presenting with cervical metastatic nodal disease but a head and neck primary site
not apparent on CT of the neck with contrast.

EXPLORATORY OBJECTIVES:

I. To compare the lesion to background (L/B) ratios for nodal metastatic disease between 18F
fluciclovine PET CT and 18F FDG PET CT.

II. To estimate the sensitivity of 18F fluciclovine PET CT and 18F FDG PET CT to detect nodal
disease.

III. To evaluate for any trends in findings on 18F fluciclovine PET CT and human
papillomavirus (HPV) status.

OUTLINE:

Patients receive fluciclovine F18 intravenously (IV) and undergo PET/CT scan over 20-30
minutes.

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