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

University Hospital, Ghent40 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Lung Neoplasms PET-CT Specimen Imager

Interventions

AURA10 Specimen ImagerDEVICE

High-resolution specimen imaging using the AURA10 PET-CT specimen imager during thoracic surgery.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

University Hospital Ghent

Ghent, Belgium

RECRUITING

Outcomes

Primary Outcomes

Perioperative success in imaging utilizing AURA10 PET-CT Specimen Imager

A measure of perioperative success in imaging 18F-FDG- uptake in resected specimens obtained during thoracic surgery utilizing a high-resolution PET-CT-scanner.

Time frame: Perioperative

Secondary Outcomes

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

Sensitivity and specificity of high-resolution 18F-FDG-PET-CT of resected lung tumors in terms of bronchial margin assessment.

Time frame: 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

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

Measure signal-to-noise ratio on post-processed PET-CT specimen images.

Time frame: Perioperative

Comparison of lesion dimensions (e.g. delineation based on percentage of SUVmax, tumor-to-background ratios based on SUVpeak).

Time frame: Perioperative

Occupational radiation exposure (µSv) to the staff in the operating room related to this study.

Time frame: Perioperative

Correlation of high-resolution 18F-FDG-PET-CT images of lamellas of the resected specimen with histopathological whole-slide images.

Central Contacts

Liesbeth Desender, prof. dr.

CONTACT

+32 9 332 63 88 liesbeth.desender@uzgent.be

Lina Vermeir

CONTACT

+32 9 332 62 58 studiestvhk@uzgent.be

Data from ClinicalTrials.gov

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