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Recruiting NCT06915454

High-Resolution PET-CT Imaging for Surgical Margin Visualization

No phase Interventional Cancer Solid Malignant Tumors SCC - Squamous Cell Carcinoma HNSCC

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Intra-op PET/CT Specimen Scanner.
Who it may be relevant to
Registry conditions: Cancer, Solid Malignant Tumors, SCC - Squamous Cell Carcinoma, HNSCC. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

High-resolution Specimen PET-CT Imaging for the Intraoperative Visualization of Resection Margins: an Exploratory Study

Overview

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.

Detailed description

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

Interventions

  • Device 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 measures

  • The study will determine the feasibility of intraoperative high-resolution specimen PET-CT imaging in solid tumors. [Time frame: Day of Surgery.]
Secondary outcome measures (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; [Time frame: 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 [Time frame: 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). [Time frame: Day of Surgery to 10 days.]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Supportive care

Study locations

United States · 1 center
  • Vanderbilt University Medical Center — Nashville

Publications

  • 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. PMID 42185750

Identifiers

NCT: NCT06915454 · VICCHNP24616

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗