High-Resolution PET-CT Imaging for Surgical Margin Visualization
High-Resolution PET-CT Imaging for Surgical Margin Visualization
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.
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.
Miscellaneous
Phase I
Adults
Not Available
Not Available
Topf, Michael
Local
Vanderbilt University
08-22-2025
Eligibility
18 Years and older
ALL
false
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.
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.
