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

Not Applicable

Recruiting

• Conditions: Lung Neoplasms; PET-CT Specimen Imager
• Interventions: Device: AURA10 Specimen Imager

• Registration Number: NCT05693363
• Lead Sponsor: University Hospital, Ghent

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-01-11
• Study First Submitted QC: 2023-01-11
• Study First Posted: 2023-01-23
• Study Start: 2024-01-01
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-13
• Last Update Posted: 2025-01-15
• Primary Completion: 2025-07-31
• Study Completion: 2025-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
18F-FDG AURA10 Specimen Imager	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)

Primary Outcome Measures

Name	Time	Method
Perioperative success in imaging utilizing AURA10 PET-CT Specimen Imager	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University Hospital Ghent; 🇧🇪 Ghent, Belgium