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

NCT ID: NCT05693363

Condition: Lung Neoplasms
PET-CT Specimen Imager

Conditions: Official terms:
Lung Neoplasms

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Diagnostic

Masking: None (Open Label)

Intervention:

Intervention type: Device
Intervention name: AURA10 Specimen Imager
Description: High-resolution specimen imaging using the AURA10 PET-CT specimen imager during thoracic surgery.
Arm group label: 18F-FDG AURA10 Specimen Imager

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.

Criteria for eligibility:
Criteria:
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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: University Hospital Ghent

Address:
City: Ghent
Zip: 9000
Country: Belgium

Status: Recruiting

Contact:
Last name: Liesbeth Desender, prof. dr.
Email: liesbeth.desender@uzgent.be

Contact backup:
Last name: Lina Vermeir

Phone: +32 9 332 62 58
Email: studiestvhk@uzgent.be

Investigator:
Last name: Liesbeth Desender, Prof. Dr.
Email: Principal Investigator

Investigator:
Last name: Alexander Croo, Dr.
Email: Sub-Investigator

Investigator:
Last name: Frédéric De Ryck, Dr.
Email: Sub-Investigator

Investigator:
Last name: Annick D'Haeninck, Dr.
Email: Sub-Investigator

Start date: January 1, 2024

Completion date: January 31, 2025

Lead sponsor:
Agency: University Hospital, Ghent
Agency class: Other

Collaborator:
Agency: XEOS Medical
Agency class: Industry

Source: University Hospital, Ghent

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05693363
https://gco.iarc.fr/today

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