High-Resolution PET-CT Imaging for Surgical Margin Visualization

NCT06915454 | Recruiting DMC FDA Device

• 1 other identifier: VICCHNP24616
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer; Solid Malignant Tumors; SCC - Squamous Cell Carcinoma; HNSCC; HNSCC,Larynx, Pharynx and Oral Cavity

Keywords

undergoing surgery; Xeos; PET/CT imaging; specimen scanner; cancer margins; oral cancer; mouth cancer; tongue cancer; gum cancer; scc; head and neck cancer; pharynx; hnscc

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (3)

• 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.

Study Arms (1)

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.

Device: Intra-op PET/CT Specimen Scanner

Interventions

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.

Also known as: XEOS Aura 10

18F-FDG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vanderbilt-Ingram Cancer Center: lead
• Vanderbilt University Medical Center: collaborator
• XEOS Medical: collaborator

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

RECRUITING

MeSH Terms

Conditions

Neoplasms; Carcinoma, Squamous Cell; Squamous Cell Carcinoma of Head and Neck; Laryngeal Diseases; Mouth Neoplasms; Tongue Neoplasms; Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms, Squamous Cell; Neoplasms by Site; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Mouth Diseases; Stomatognathic Diseases; Tongue Diseases

Study Officials

• Michael Topf, MD

  Vanderbilt University/Ingram Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nicole Jones

CONTACT

615-936-2807; nicole.l.jones@vumc.org

Kyrionna Golliday

CONTACT

615-421-1585; kyrionna.m.golliday@vumc.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor - Head & Neck Surgical Oncology-Microvascular Reconstruction

Study Record Dates

• First Submitted: March 27, 2025
• First Posted: April 8, 2025
• Study Start: September 3, 2025
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: October 3, 2025

Record last verified: 2025-09

Locations

US (1)