High-resolution PET-CT to visualize surgical tumor margins
High-resolution Specimen PET-CT Imaging for the Intraoperative Visualization of Resection Margins: an Exploratory Study
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Vanderbilt-Ingram Cancer Center Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Nashville, Tennessee) |
| Trial ID | NCT06915454 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Nashville, Tennessee
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.