Perioperative Specimen Imaging Using High-resolution 18F-FDG-PET-CT During Thoracic Surgery: a Pilot Study (ThorPET)

January 13, 2025 updated by: University Hospital, Ghent
In this pilot study the investigators propose the intraoperative use of a high-resolution PET-CT imaging system which can assess resection margins and lymph node status in the operating room. This will allow for a faster and stepwise assessment (estimated to be under 10 minutes per specimen), enabling the surgeon to decide on subsequent surgical steps after each previous assessment.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Belgium
      • Ghent, Belgium, 9000
        • Recruiting
        • University Hospital Ghent
        • Contact:
        • Contact:
        • Contact:
          • Liesbeth Desender, Prof. Dr.
        • Contact:
          • Alexander Croo, Dr.
        • Contact:
          • Frédéric De Ryck, Dr.
        • Contact:
          • Annick D'Haeninck, Dr.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patient is 18 years of age or older.
  • Patient with suspected or confirmed lung malignancies
  • Patient is indicated to undergo thoracic surgery.
  • Patient is estimated to be compliant for study participation by the investigator.
  • Patient has freely given his/her informed consent to participate in this study.

Exclusion Criteria:

  • Patient has general or local contra-indications for thoracic surgery.
  • Patient has active infection.
  • Blood glucose level over 200 mg/dL on the day of surgery.
  • Pregnancy or lactation.
  • Patient participated in other clinical studies with radiation exposure of more than 1 mSv in the past year

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 18F-FDG AURA10 Specimen Imager
  • Intravenous injection of radiotracer (18F-FDG) (study-specific)
  • Thoracic surgery (standard-of-care; not study-specific)
  • High-resolution specimen imaging using the AURA10 PET-CT specimen imager (study-specific)
  • Postoperative histopathological analysis of specimen (standard-of-care)
Device: AURA10 Specimen Imager
High-resolution specimen imaging using the AURA10 PET-CT specimen imager during thoracic surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Perioperative success in imaging utilizing AURA10 PET-CT Specimen Imager
Time Frame: Perioperative
A measure of perioperative success in imaging 18F-FDG- uptake in resected specimens obtained during thoracic surgery utilizing a high-resolution PET-CT-scanner.
Perioperative

Secondary Outcome Measures

Outcome Measure
Time Frame
Sensitivity and specificity of high-resolution 18F-FDG-PET-CT of resected mediastinal or thoracic lymph nodes in terms of nodal staging.
Time Frame: Perioperative
Perioperative
Sensitivity and specificity of high-resolution 18F-FDG-PET-CT of resected lung tumors in terms of bronchial margin assessment.
Time Frame: Perioperative
Perioperative
Sensitivity and specificity of high-resolution 18F-FDG-PET-CT of resected lung tumors in terms of lung parenchyma margin assessment
Time Frame: Perioperative
Perioperative
Correlation between 18F-FDG uptake in the resected specimens and histopathological characteristics of the tumor, such as the type, grade, or stage of the tumor.
Time Frame: Perioperative
Perioperative
Measure signal-to-noise ratio on post-processed PET-CT specimen images.
Time Frame: Perioperative
Perioperative
Comparison of lesion dimensions (e.g. delineation based on percentage of SUVmax, tumor-to-background ratios based on SUVpeak).
Time Frame: Perioperative
Perioperative
Occupational radiation exposure (µSv) to the staff in the operating room related to this study.
Time Frame: Perioperative
Perioperative
Correlation of high-resolution 18F-FDG-PET-CT images of lamellas of the resected specimen with histopathological whole-slide images.
Time Frame: Perioperative
Perioperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Ghent

Collaborators

XEOS Medical

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2024

Primary Completion (Estimated)

July 31, 2025

Study Completion (Estimated)

July 31, 2025

Study Registration Dates

First Submitted

January 11, 2023

First Submitted That Met QC Criteria

January 11, 2023

First Posted (Actual)

January 23, 2023

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 13, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ONZ-2023-0105

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Lung Neoplasms

Clinical Trials on AURA10 Specimen Imager

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Ghana

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe