Clareo Health | Fluciclovine F18 PET/CT in Identifying the Origin of Head and Neck Squamous Cell Carcinoma in Patients With Metastatic Cervical Nodal Disease
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Lead
M.D. Anderson Cancer Center
With
National Cancer Institute (NCI)
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.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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