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
3 other identifiers
interventional
16
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for early_phase_1
Started Apr 2019
Longer than P75 for early_phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 7, 2019
CompletedFirst Posted
Study publicly available on registry
March 8, 2019
CompletedStudy Start
First participant enrolled
April 24, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 22, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
March 22, 2024
CompletedMarch 28, 2024
March 1, 2024
4.9 years
March 7, 2019
March 26, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
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
Other Outcomes (2)
Lesion to background (L/B) ratios for nodal metastatic disease
Up to 2 years
Sensitivity and specificity in detecting nodal disease
Up to 2 years
Study Arms (1)
Diagnostic (fluciclovine F18 PET/CT)
EXPERIMENTALPatients receive fluciclovine F18 IV and undergo PET/CT scan over 20-30 minutes.
Interventions
Undergo PET/CT
Given IV
Undergo PET/CT
Eligibility Criteria
You may qualify 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 qualify 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- M.D. Anderson Cancer Centerlead
- National Cancer Institute (NCI)collaborator
Study Sites (1)
M D Anderson Cancer Center
Houston, Texas, 77030, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Maria K Gule-Monroe
M.D. Anderson Cancer Center
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 7, 2019
First Posted
March 8, 2019
Study Start
April 24, 2019
Primary Completion
March 22, 2024
Study Completion
March 22, 2024
Last Updated
March 28, 2024
Record last verified: 2024-03