Recruiting

Imaging Device

Sponsor:

Vanderbilt-Ingram Cancer Center

Code:

NCT06915454

Conditions

Cancer

Solid Malignant Tumors

SCC - Squamous Cell Carcinoma

HNSCC

HNSCC,Larynx, Pharynx and Oral Cavity

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Intra-op PET/CT Specimen Scanner

Study Details

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

Study ID

NCT06915454

Start date

Sep 3, 2025

Status verified date

May, 2026

Completion date

Jul, 2027

Anticipated

Primary completion date

May, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

50 participants

Anticipated

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

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.

Interventions

Intra-op PET/CT Specimen Scanner

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.

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 and Locations

Central contacts

Nicole Jones

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

Kyrionna Golliday

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

Locations

Vanderbilt University Medical Center

Recruiting

Nashville, Tennessee, United States, 37232

Contacts

Nicole Jones

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

Kyrionna Golliday

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

Principal Investigator:

Michael Topf, MD

More Information

Sponsor

Vanderbilt-Ingram Cancer Center

Last update posted

May 8, 2026

Last verified

May, 2026

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Vanderbilt-Ingram Cancer Center on 2026-05-08.