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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