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| Name | Class |
|---|---|
| Vanderbilt University Medical Center | OTHER |
| XEOS Medical | INDUSTRY |
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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 18F-FDG | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intra-op PET/CT Specimen Scanner | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| The study will determine the feasibility of intraoperative high-resolution specimen PET-CT imaging in solid tumors. | 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. |
| 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; | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nicole Jones | Contact | 615-936-2807 | nicole.l.jones@vumc.org | |
| Kyrionna Golliday | Contact | 615-421-1585 | kyrionna.m.golliday@vumc.org |
| Name | Affiliation | Role |
|---|---|---|
| Michael Topf, MD | Vanderbilt University/Ingram Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanderbilt University Medical Center | Recruiting | Nashville | Tennessee | 37232 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42185750 | Derived | Radevic A, Austerlitz J, McAdoo A, Golliday K, Takahashi T, Mehrad M, Rosenberg AJ, Murphy BA, Rosenthal E, Topf MC. Visualization of Scattered Tumor Regression Following Neoadjuvant Chemoimmunotherapy With a Novel Intraoperative PET/CT Scanner. Head Neck. 2026 May 25. doi: 10.1002/hed.70333. Online ahead of print. |
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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.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Jul 30, 2025 | Sep 29, 2025 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D002294 | Carcinoma, Squamous Cell |
| D000077195 | Squamous Cell Carcinoma of Head and Neck |
| D007818 | Laryngeal Diseases |
| D009062 | Mouth Neoplasms |
| D014062 | Tongue Neoplasms |
| D006258 | Head and Neck Neoplasms |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D018307 | Neoplasms, Squamous Cell |
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| 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 |
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). | Researchers will compare standard of care imaging data to the XEOS Aura 10 specimen scanner data. | Day of Surgery to 10 days. |
| D009371 | Neoplasms by Site |
| D012140 | Respiratory Tract Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D014060 | Tongue Diseases |