High-Resolution PET-CT Imaging for Surgical Margin Visualization

Part of paid clinical trials in Nashville, Tennessee.

Sponsor
Vanderbilt-Ingram Cancer Center
Study ID
NCT06915454
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

Start date
Sep 3, 2025
Status verified
May 2026
Primary completion
May 31, 2027
Completion
Jul 31, 2027

Study Design

Enrollment
50 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE

Arms

  • 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.

Primary Outcome Measure

The study will determine the feasibility of intraoperative high-resolution specimen PET-CT imaging in solid tumors. [ Time Frame: Day of Surgery. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Vanderbilt University Medical CenterNashvilleTennessee37232
Nicole Jones
[email protected]
615-936-2807
Kyrionna Golliday
[email protected]
615-421-1585
Michael Topf, MD (PRINCIPAL_INVESTIGATOR)

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