Perioperative Specimen Imaging Using High-resolution 18F-FDG-PET-CT During Thoracic Surgery: a Pilot Study
Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
Belgium
University Hospital Ghent
RECRUITING
Ghent
Contact Information
Primary
Liesbeth Desender, prof. dr.
liesbeth.desender@uzgent.be
+32 9 332 63 88
Backup
Lina Vermeir
studiestvhk@uzgent.be
+32 9 332 62 58
Time Frame
Start Date: 2024-01-01
Estimated Completion Date: 2025-07-31
Participants
Target number of participants: 40
Treatments
Experimental: 18F-FDG 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)
Related Therapeutic Areas
Sponsors
Collaborators: XEOS Medical
Leads: University Hospital, Ghent