High-Resolution PET-CT Imaging for Surgical Margin Visualization
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
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Nicole Jones
- Phone Number: 615-936-2807
- Email: nicole.l.jones@vumc.org
Study Contact Backup
- Name: Kyrionna Golliday
- Phone Number: 615-421-1585
- Email: kyrionna.m.golliday@vumc.org
Study Locations
-
-
Tennessee
-
Nashville, Tennessee, United States, 37232
- Recruiting
- Vanderbilt University Medical Center
-
Principal Investigator:
- Michael Topf, MD
-
Contact:
- Nicole Jones
- Phone Number: 615-936-2807
- Email: nicole.l.jones@vumc.org
-
Contact:
- Kyrionna Golliday
- Phone Number: 615-421-1585
- Email: kyrionna.m.golliday@vumc.org
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
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
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. |
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:
|
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
Sponsor
Investigators
- Principal Investigator: Michael Topf, MD, Vanderbilt University/Ingram Cancer Center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mouth Diseases
- Stomatognathic Diseases
- Neoplasms by Site
- Respiratory Tract Diseases
- Neoplasms by Histologic Type
- Neoplasms, Glandular and Epithelial
- Carcinoma
- Neoplasms, Squamous Cell
- Otorhinolaryngologic Diseases
- Tongue Diseases
- Squamous Cell Carcinoma of Head and Neck
- Neoplasms
- Carcinoma, Squamous Cell
- Head and Neck Neoplasms
- Mouth Neoplasms
- Tongue Neoplasms
- Laryngeal Diseases
Other Study ID Numbers
- VICCHNP24616
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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.