Clinical trial NCT06915454: High-Resolution PET-CT Imaging for Surgical Margin Visualization
Official title: High-resolution Specimen PET-CT Imaging for the Intraoperative Visualization of Resection Margins: an Exploratory Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cancer
Solid Malignant Tumors
Keywords: undergoing surgery
Xeos
PET/CT imaging
specimen scanner
cancer margins
Lead sponsor: Vanderbilt-Ingram Cancer Center
Sponsor class: OTHER
Collaborators: name: Vanderbilt University Medical Center
First posted: 2025-04-08
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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

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 Investigator determines that patient could be at risk.

Primary outcomes:
measure: The study will determine the feasibility of intraoperative high-resolution specimen PET-CT imaging in solid tumors.
timeFrame: Day of Surgery.
Secondary outcomes:
measure: Correlate the margin status based on high-resolution specimen PET-CT images with the actual margin status based on gold standard microscopic histopathological analysis;
timeFrame: Day of Surgery to Pathology
measure: 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
timeFrame: Day of Surgery to Pathology
measure: 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).
timeFrame: Day of Surgery to 10 days.
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University/Ingram Cancer Center
name: Michael Topf, MD
role: PRINCIPAL_INVESTIGATOR
References: