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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
Who can join
Ages 18 and older · All sexes
Full eligibility 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.
About the study
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.
What is being tested
- Intra-op PET/CT Specimen Scanner (device)
Sponsor: Vanderbilt-Ingram Cancer Center · Participants: 50 · Started: Sep 3, 2025
Contact the study team
- Nicole Jones · Phone: 615-936-2807
- Kyrionna Golliday · Phone: 615-421-1585
Official record on ClinicalTrials.gov — NCT06915454
Locations in the U.S.
| Tennessee | Vanderbilt University Medical Center, Nashville |
Conditions
- Cancer (all types)
- Squamous Cell Carcinoma
- Head and Neck Squamous Cell Carcinoma
- Oral Cancer
- Tongue Cancer
- Head and Neck Cancer
From ClinicalTrials.gov, data retrieved Oct 1, 2026. Each study sets its own eligibility; the study team decides who can join.