Back to search results
NCT06915454

High-Resolution PET-CT Imaging for Surgical Margin Visualization

Recruiting
NAAges 18+InterventionalSupportive care
Vanderbilt-Ingram Cancer Center
~50 participants
Updated 2026-05-08 on ClinicalTrials.gov
What's tested:Intra-op PET/CT Specimen Scanner

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
The study will determine the feasibility of intraoperative high-resolution specimen PET-CT imaging in solid tumors.
Measured over Day of Surgery.

Conditions

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

Explore related trials

Solid NeoplasmSquamous Cell Carcinoma

Where it's being run

1 sites across 1 states
Tennessee1

Study leadership

  • Michael Topf, MD · PRINCIPAL_INVESTIGATOR · Vanderbilt University/Ingram Cancer Center

Who to contact

Nicole Jones
[email protected]
615-936-2807
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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

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.

What this trial measures

  • The study will determine the feasibility of intraoperative high-resolution specimen PET-CT imaging in solid tumors.Day of Surgery.

    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.