Status:
RECRUITING
High-Resolution PET-CT Imaging for Surgical Margin Visualization
Lead Sponsor:
Vanderbilt-Ingram Cancer Center
Collaborating Sponsors:
Vanderbilt University Medical Center
XEOS Medical
Conditions:
Cancer
Solid Malignant Tumors
Eligibility:
All Genders
18+ years
Phase:
NA
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...
Detailed Description
This pilot study explores the use of high-resolution PET imaging to identify surgical margins in solid tumors after removal. It evaluates the feasibility and potential of using PET-CT to assess tumor ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 3 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2027
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06915454
Start Date
September 3 2025
End Date
July 1 2027
Last Update
October 3 2025
Active Locations (1)
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1
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232