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

Inclusion Criteria7

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 Criteria4

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.

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.