NCT03868020CompletedEarly phase 1
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 · Last updated 28 Mar 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Early phase 1
- Study type
- Interventional
- Enrollment
- 16 (actual)
- First submitted
- 7 Mar 2019
- Start date
- 24 Apr 2019
- Primary completion date
- 22 Mar 2024
- Lead sponsor
- M.D. Anderson Cancer Center
- Diseases
- Head and neck cancer
- NCT number
- NCT03868020
What you commit to
- Study type: Interventional · Early phase 1
- Participants enrolled: 16
- From 24 Apr 2019 to the primary completion date, 22 Mar 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Known allergy to FDG, fluciclovine, or iodine-based contrast agents
Other
- Pregnant women
- Severe renal dysfunction (glomerular filtrate rate \[within 30 days\] less than 30)
- Inability to tolerate lying supine, relatively motionless for up to 1 hour
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| M D Anderson Cancer Center Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.