18F-FDG micro-PET/CT for intra-operative margin assessment during breast-conserving surgery.
Menekse Göker, Radosław Marcinkowski, Mieke Van Bockstal...
https://pubmed.ncbi.nlm.nih.gov/32452298Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID05693363
Perioperative Specimen Imaging Using High-resolution 18F-FDG-PET-CT During Thoracic Surgery: a Pilot Study
Led by University Hospital, Ghent · Updated on 2025-01-15
40
Participants Needed
1
Research Sites
82 weeks
Total Duration
On this page
Sponsors
U
University Hospital, Ghent
Lead Sponsor
X
XEOS Medical
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the use of a high-resolution PET-CT imaging device called the AURA10 Specimen Imager during thoracic surgery for patients with suspected or confirmed lung malignancies. This pilot study aims to quickly assess surgical specimen margins and lymph node status right in the operating room, helping surgeons make immediate decisions about further surgical steps. The imaging process is estimated to take less than 10 minutes per specimen. During the surgery, the AURA10 Specimen Imager is used intraoperatively to provide detailed PET-CT images of the removed tissue. This allows for stepwise assessment after each specimen is evaluated. The study focuses on the perioperative period, where the imaging device is applied to help guide surgical decisions more efficiently. Participants will undergo thoracic surgery and have their specimens imaged using the AURA10 device during the operation. Researchers will measure perioperative success in imaging with this system. Participants must be at least 18 years old and able to comply with study procedures. Safety monitoring includes checking blood glucose levels and screening for infections or conditions that may prevent surgery. The total study involvement is centered around the surgery and immediate perioperative imaging process.
CONDITIONS
Official Title
Perioperative Specimen Imaging Using High-resolution 18F-FDG-PET-CT During Thoracic Surgery: a Pilot Study
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- 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.
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Trial Site Locations
Total: 1 location
1
University Hospital Ghent
Ghent, Belgium, 9000
Actively Recruiting
Loading map...
Research Team
L
Liesbeth Desender, prof. dr.
L
Lina Vermeir
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here
Published Research Related To This Trial
Radiation Dosimetry and Biodistribution of 18F-PSMA-11 for PET Imaging of Prostate Cancer.
Sarah Piron, Kathia De Man, Nick Van Laeken...
https://pubmed.ncbi.nlm.nih.gov/31028165