Clinical trial · Interventional
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
NCT06915454CI-TRIAL-00110959recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| HNSCC | Head and Neck Squamous Cell Carcinoma | ALIAS | 0.90 |
| HNSCC,Larynx, Pharynx and Oral Cavity | Head and Neck Squamous Cell Carcinoma | ALIAS | 0.85 |
| SCC - Squamous Cell Carcinoma | — | UNRESOLVED | — |
| Solid Malignant Tumors | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Intra-op PET/CT Specimen Scanner | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 18F-FDG
- description
- 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.
- interventionNames
- Device: Intra-op PET/CT Specimen Scanner
Primary outcomes (1)
- measure
- The study will determine the feasibility of intraoperative high-resolution specimen PET-CT imaging in solid tumors.
- timeFrame
- Day of Surgery.
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDRadevic 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 25:10.1002/hed.70333. doi: 10.1002/hed.70333. Online ahead of print. PMID 42185750