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

Ghent University Hospital (UZ)

Status: Enrolling

Conditions: Lung Neoplasms; PET-CT Specimen Imager

Treatments: Device: AURA10 Specimen Imager

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05693363

ONZ-2023-0105

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

18F-FDG AURA10 Specimen Imager

Experimental group

Description:

* 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)

Treatment:

Device: AURA10 Specimen Imager