High-Resolution PET-CT Imaging for Surgical Margin Visualization
Trial Parameters
Brief 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 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 I