High-resolution PET-CT to visualize surgical tumor margins
Official title: High-resolution Specimen PET-CT Imaging for the Intraoperative Visualization of Resection Margins: an Exploratory Study
Run by Vanderbilt-Ingram Cancer Center · NCT06915454 · Data updated 2026-11-12
This will test whether a low-dose, high-resolution PET-CT scan of removed tumor tissue can help surgeons spot at-risk margins during surgery for adults with solid cancers such as head and neck squamous cell carcinoma.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 50 (estimated) |
| Sponsor | Vanderbilt-Ingram Cancer Center Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Nashville, Tennessee) |
| Status | Recruiting |
| Started | September 3, 2025 |
| Main results expected | May 2027 |
| Study ends | July 2027 |
| Registry record updated | May 8, 2026 |
| Trial ID | NCT06915454 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults (≥18) with biopsy-confirmed solid malignancies scheduled for curative en bloc surgical resection, with acceptable performance status (Karnofsky ≥70 or ECOG ≤1), life expectancy >12 weeks, and blood glucose <200 mg/dL on the day of surgery.
✕Probably not a fit
Patients not undergoing resective surgery, those who are pregnant or breastfeeding, individuals with uncontrolled blood glucose, or those with contraindications to surgery are unlikely to receive benefit from this imaging procedure.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This pilot uses an intraoperative ex vivo PET/CT specimen scanner to image resected tumor tissue after a reduced 18F-FDG injection (about 20% of the standard dose) to explore feasibility and image quality. Imaging is performed during the scheduled surgical procedure and does not change the standard-of-care resection. The study focuses on whether high-resolution PET can identify close or positive margins while maintaining radiation safety. Prior proof-of-concept work in breast, pancreatic, prostate, and head-and-neck tumors supports the underlying approach.
Why it matters
Potential benefit: If successful, this could help surgeons more accurately identify and remove cancerous tissue, reducing the chance of positive margins and the need for repeat surgeries.
How similar studies have gone: Prior small studies using ex vivo PET imaging have shown good tumor visualization in breast, pancreatic, prostate, and head-and-neck cancers, providing proof-of-concept for this approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * General or local contraindications for resective surgery * Women who are pregnant or breast-feeding * Blood glucose level over 200 mg/dL prior to 18F-FDG infusion * 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.
Where it's running
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Vanderbilt University Medical Center
Nashville, Tennessee, United States Recruiting
Study contacts
- Principal investigator: Michael Topf, MD — Vanderbilt University/Ingram Cancer Center
- Study coordinator: Nicole Jones
- Email: nicole.l.jones@vumc.org
- Phone: 615-936-2807
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.