Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Head and Neck Squamous Cell Carcinoma | Head and Neck Squamous Cell Carcinoma | CURATED_BROADER | 0.78 |
| Metastatic Squamous Cell Carcinoma in Cervical Lymph Node | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Computed Tomography | Procedure | — | UNRESOLVED |
| Fluciclovine F18 | Radiation | — | UNRESOLVED |
| Positron Emission Tomography | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Diagnostic (fluciclovine F18 PET/CT)
- description
- Patients receive fluciclovine F18 IV and undergo PET/CT scan over 20-30 minutes.
- interventionNames
- Procedure: Computed Tomography
- Radiation: Fluciclovine F18
- Procedure: Positron Emission Tomography
Primary outcomes (1)
- measure
- Proportion of the suspected lesions that are positive by the gold standard of pathology
- timeFrame
- Up to 2 years
- description
- Positive predicative values will be estimated with a corresponding exact 95% confidence interval.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Criteria: * 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
References
Publications (0)
Data not yet available