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

Study Overview
=================
Brief 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.

Detailed Description
-----------------
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.

Official Title
-----------------
Pilot Study of 18F Fluciclovine PET CT in Identification of the Primary in Patients With an Unknown Primary Head and Neck Squamous Cell Carcinoma Presenting With Metastatic Cervical Nodal Disease

Conditions
-----------------
Metastatic Head and Neck Squamous Cell Carcinoma, Metastatic Squamous Cell Carcinoma in Cervical Lymph Node

Intervention / Treatment
-----------------
* Procedure: Computed Tomography
* Radiation: Fluciclovine F18
* Procedure: Positron Emission Tomography


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Diagnostic (fluciclovine F18 PET/CT)<br>Patients receive fluciclovine F18 IV and undergo PET/CT scan over 20-30 minutes. | Procedure: Computed Tomography<br>* Undergo PET/CT<br>* Other names: tomography;Radiation: Fluciclovine F18<br>* Given IV<br>* Other names: GE-148 F-18;Procedure: Positron Emission Tomography<br>* Undergo PET/CT<br>* Other names: proton magnetic resonance spectroscopic imaging;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of the suspected lesions that are positive by the gold standard of pathology | Positive predicative values will be estimated with a corresponding exact 95% confidence interval. | Up to 2 years |