High-Resolution PET-CT Imaging for Surgical Margin Visualization

May 6, 2026 updated by: Michael Topf, Vanderbilt-Ingram Cancer Center

High-resolution Specimen PET-CT Imaging for the Intraoperative Visualization of Resection Margins: an Exploratory Study

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 specimens and ensures radiation safety with a low-dose 18-FDG injection (20% of the standard dose). Previous studies have shown good tumor visualization in breast, pancreatic, prostate, and head and neck tumors, supporting the method's proof-of-concept. This research aims to gather insights into its clinical usefulness across different cases

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Recruiting
        • Vanderbilt University Medical Center
        • Principal Investigator:
          • Michael Topf, MD
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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.
Other Names:
  • XEOS Aura 10

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The study will determine the feasibility of intraoperative high-resolution specimen PET-CT imaging in solid tumors.
Time Frame: Day of Surgery.

This study is an exploratory pilot study where the main goal is to gather scientific knowledge. Since no results with a certain significance need to be proven, no power analysis will be performed.

Pre-Surgery Preparation: Patients are injected with a PET (18F-FDG) tracer. This tracer highlights cancerous tissues by emitting signals detectable by PET imaging.

Intraoperative Imaging: Once the tumor is removed, the specimen is scanned using the XEOS Aura 10 device in the operating room. This allows surgeons to get detailed images of the tumor and surrounding tissues.

Immediate Analysis: The imaging provides real-time feedback on the tumor's characteristics, such as margins and whether all cancerous tissue has been removed. This can help surgeons make decisions during the operation, like whether additional tissue needs to be excised.

Comparison with Pathology: The PET-CT images are later compared with traditional pathology results to validate their accuracy and usefulness.
Day of Surgery.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlate the margin status based on high-resolution specimen PET-CT images with the actual margin status based on gold standard microscopic histopathological analysis;
Time Frame: Day of Surgery to Pathology
Researchers will compare pathology data that is to be completed as standard of care to the XEOS Aura 10 specimen scanner margins.
Day of Surgery to Pathology
Correlate lymph node status based on high-resolution specimen PET-CT images with the actual lymph node status based on gold standard microscopic histopathological analysis
Time Frame: Day of Surgery to Pathology
Researchers will compare pathology data that is to be completed as standard of care to the XEOS Aura 10 specimen scanner margins.
Day of Surgery to Pathology
Compare the visualization of the target lesion between intraoperative high-resolution specimen PET-CT imaging and pre-operative whole-body PET-CT imaging (when performed per standard of care oncologic work-up).
Time Frame: Day of Surgery to 10 days.
Researchers will compare standard of care imaging data to the XEOS Aura 10 specimen scanner data.
Day of Surgery to 10 days.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vanderbilt-Ingram Cancer Center

Collaborators

Vanderbilt University Medical Center
XEOS Medical

Investigators

  • Principal Investigator: Michael Topf, MD, Vanderbilt University/Ingram Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 3, 2025

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

July 1, 2027

Study Registration Dates

First Submitted

March 27, 2025

First Submitted That Met QC Criteria

April 3, 2025

First Posted (Actual)

April 8, 2025

Study Record Updates

Last Update Posted (Actual)

May 8, 2026

Last Update Submitted That Met QC Criteria

May 6, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VICCHNP24616

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

We plan to share the data and key findings from our pilot study, which explored the feasibility and potential of high-resolution PET imaging for assessing surgical margins in solid tumors. This information will be made available to support further research, foster collaboration, and provide insights into the clinical application of ex vivo PET-CT imaging in oncology. Our findings include promising results from studies on various tumor types, highlighting the technique's ability to visualize tumors effectively with a low-dose radiation protocol.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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