Status:
COMPLETED
Fluciclovine F18 PET/CT in Identifying the Origin of Head and Neck Squamous Cell Carcinoma in Patients With Metastatic Cervical Nodal Disease
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Metastatic Head and Neck Squamous Cell Carcinoma
Metastatic Squamous Cell Carcinoma in Cervical Lymph Node
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
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 patie...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 24 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 22 2024
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT03868020
Start Date
April 24 2019
End Date
March 22 2024
Last Update
March 28 2024
Active Locations (1)
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1
M D Anderson Cancer Center
Houston, Texas, United States, 77030