RecruitingNot ApplicableNCT06915454

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

Sponsor

Vanderbilt-Ingram Cancer Center

Enrollment

50 participants

Start Date

Sep 3, 2025

Study Type

INTERVENTIONAL

Conditions

Cancer HNSCC SCC - Squamous Cell Carcinoma HNSCC,Larynx, Pharynx and Oral Cavity Solid Malignant Tumors

Summary

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing the use of high-resolution PET-CT imaging (a type of advanced scan) directly in the operating room to help surgeons see cancer margins more clearly during tumor removal surgery. The goal is to reduce the chance of leaving cancer cells behind. **You may be eligible if...** - You are 18 or older and have been diagnosed with any solid cancer tumor - You are scheduled for curative surgery to remove the tumor - You have a good performance status (able to carry out most normal activities) - Your blood sugar level is under 200 mg/dL on the day of surgery **You may NOT be eligible if...** - You are pregnant or breastfeeding - Your blood sugar is above 200 mg/dL before the scan - You have had significant radiation exposure from research studies in the past year (though standard medical radiation does not automatically exclude you) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEIntra-op PET/CT Specimen Scanner

Once the tumor or cancer is resected, it will then be imaged with the XEOS Aura 10 PET/CT Imaging Device. Imaging will be obtained utilizing a XEOS AURA 10 scanner in real time while in the operating room with the surgery team still present.