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

Metastatic Head and Neck Squamous Cell Carcinoma Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

  • Carcinoma
  • Carcinoma, Squamous Cell
  • Metastatic Head and Neck Squamous Cell Carcinoma
  • Metastatic Squamous Cell Carcinoma in Cervical Lymph Node
  • Squamous Cell Carcinoma of Head and Neck
Clinical Trial Details
NCT number NCT03868020
Study type Interventional
Source M.D. Anderson Cancer Center
Contact
Status Completed
Phase Early Phase 1
Start date April 24, 2019
Completion date March 22, 2024
View Details
See also
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