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.
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
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.
Vanderbilt-Ingram Cancer Center
Lead sponsor
Vanderbilt University Medical Center
Collaborator
XEOS Medical
Collaborator