RecruitingNot ApplicableNCT05693363

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


Sponsor

University Hospital, Ghent

Enrollment

40 participants

Start Date

Jan 1, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria5

  • 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 Criteria5

  • 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

Interventions

DEVICEAURA10 Specimen Imager

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


Locations(1)

University Hospital Ghent

Ghent, Belgium

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NCT05693363


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