University Hospital, Ghent
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.
Lung Neoplasms
PET-CT Specimen Imager
AURA10 Specimen Imager
Not Applicable
| Study Type : | Interventional |
| Estimated Enrollment : | 40 participants |
| Masking : | None (Open Label) |
| Primary Purpose : | Diagnostic |
| Official Title : | Perioperative Specimen Imaging Using High-resolution 18F-FDG-PET-CT During Thoracic Surgery: a Pilot Study |
| Actual Study Start Date : | January 1, 2024 |
| Estimated Primary Completion Date : | December 31, 2024 |
| Estimated Study Completion Date : | January 31, 2025 |
| Arm | Intervention/treatment |
|---|---|
|
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) |
Device: AURA10 Specimen Imager |
| Ages Eligible for Study: | 18 Years |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
Recruiting
University Hospital Ghent
Ghent, Belgium, 9000