High-Resolution PET-CT Imaging for Surgical Margin Visualization
NCT ID: NCT06915454
Last Updated: 2025-10-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
50 participants
INTERVENTIONAL
2025-09-03
2027-07-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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18F-FDG
After confirming inclusion/exclusion criteria, all participants will receive a one-time IV infusion of 18 F-FDG dose prior to surgical extirpation of tumor. Administration of 18 F-FDG will be injected as a bolus during surgery. Appropriate medical resources for the treatment of severe infusion reactions should be available during infusions, although these are not expected.
Once the tumor or cancer is resected, it will then be imaged with the XEOS Aura 10 PET/CT Imaging Device.
Intra-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.
Interventions
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Intra-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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Vanderbilt University Medical Center
OTHER
XEOS Medical
INDUSTRY
Vanderbilt-Ingram Cancer Center
OTHER
Responsible Party
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Michael Topf
Assistant Professor - Head & Neck Surgical Oncology-Microvascular Reconstruction
Principal Investigators
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Michael Topf, MD
Role: PRINCIPAL_INVESTIGATOR
Vanderbilt University/Ingram Cancer Center
Locations
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Vanderbilt University Medical Center
Nashville, Tennessee, United States
Countries
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Central Contacts
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Facility Contacts
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Provided Documents
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Document Type: Informed Consent Form
Other Identifiers
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VICCHNP24616
Identifier Type: -
Identifier Source: org_study_id
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