NCT03868020

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

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

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Metastatic Head and Neck Squamous Cell Carcinoma
• Metastatic Squamous Cell Carcinoma in Cervical Lymph Node

Interventions

Type	Name	Description
PROCEDURE	Computed Tomography	Undergo PET/CT
RADIATION	Fluciclovine F18	Given IV
PROCEDURE	Positron Emission Tomography	Undergo PET/CT

Timeline

• Start date: 2019-04-24
• Primary completion: 2024-03-22
• Completion: 2024-03-22
• First posted: 2019-03-08
• Last updated: 2024-03-28

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study