High-resolution Specimen PET-CT Imaging for the Intraoperative Visualization of Resection Margins: an Exploratory Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- The study will determine the feasibility of intraoperative high-resolution specimen PET-CT imaging in solid tumors.
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
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.
Intervention: Intra-op PET/CT Specimen Scanner (Device)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Correlate the margin status based on high-resolution specimen PET-CT images with the actual margin status based on gold standard microscopic histopathological analysis;(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(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).(Day of Surgery to 10 days.)
Investigators
Michael Topf
Assistant Professor - Head & Neck Surgical Oncology-Microvascular Reconstruction
Vanderbilt-Ingram Cancer Center