NCT06915454Recruiting
High-Resolution PET-CT Imaging for Surgical Margin Visualization
High-resolution Specimen PET-CT Imaging for the Intraoperative Visualization of Resection Margins: an Exploratory Study
Source: ClinicalTrials.gov · Last updated 8 May 2026
Brief summary (registry, in English)
Imaging will be exploratory and be used intraoperatively. There have been no discovered risks associated with the device to be used in this study, and none are anticipated given the diagnostic and non-invasive, 'ex vivo' nature of device use. Of note, the surgical resection will proceed as per standard of care and will not be affected by the research protocol. Potential Benefit: Imaging intra-operatively will ensure surgeons to identify at risk resection margins. Time Commitment: There are no additional visits that will be asked of you to partake in this study. Drug is FDA approved and Exposure to Radiation is minimal.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- First submitted
- 27 Mar 2025
- Start date
- 3 Sept 2025
- Primary completion date
- May 2027
- Lead sponsor
- Vanderbilt-Ingram Cancer Center
- Diseases
- Head and neck cancer
- NCT number
- NCT06915454
What you commit to
- Study type: Interventional
- Planned participants: 50
- From 3 Sept 2025 to the primary completion date, May 2027
- 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.
Prior treatment
- General or local contraindications for resective surgery
- Any participation in other clinical trials or research study that involved a radiation exposure of more than 1 mSv in the past year. If the participant had radiation exposure greater than 1 mSv as SOC, they would not be excluded unless the Principal Investigator determines that patient could be at risk.
Lab values
- Blood glucose level over 200 mg/dL prior to 18F-FDG infusion
Other
- Women who are pregnant or breast-feeding
Who the study is looking for
- Biopsy confirmed diagnosis of any solid malignancy
- Diagnosis of any T stage, any subsite that are scheduled to undergo definitive en bloc surgical resection. Patients with recurrent disease or a new primary will be allowed.
- Planned standard of care oncologic surgery with curative intent
- Male or female patients age ≥ 18 years
- Have life expectancy of more than 12 weeks
- Karnofsky performance status of at least 70% or ECOG/Zubrod level 1
- Have acceptable glucose status (\<200 mg/dL) at Day of Surgery prior to 18F-FDG injection
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 |
|---|---|---|---|
| Vanderbilt University Medical Center Coordinator of this site? Confirm its status | Nashville | United States | Recruiting |
Related publications
- Visualization of Scattered Tumor Regression Following Neoadjuvant Chemoimmunotherapy With a Novel Intraoperative PET/CT Scanner.Head Neck · 2026 · PMID 42185750
This page is information, not medical advice. Discuss any trial with your doctor.