Perioperative Specimen Imaging Using High-resolution 18F-FDG-PET-CT During Thoracic Surgery: a Pilot Study
Recruiting · NCT05693363 · Interventional (participants receive a specific treatment) · Lead sponsor: University Hospital, Ghent
View the official record on ClinicalTrials.gov →Interventions studied
AURA10 Specimen Imager
What this trial is 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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
1 location listed.
- University Hospital Ghent - Ghent, Belgium