Actively Recruiting
High-resolution PET-CT Specimen Imaging for the Perioperative Visualization of Resection Margins: an Exploratory Pilot Study
Led by Algemeen Ziekenhuis Maria Middelares · Updated on 2025-02-19
150
Participants Needed
1
Research Sites
21 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to improve the surgical treatment of patients with benign or malignant tumors that require removal. The study evaluates the use of high-resolution PET-CT imaging on tissue specimens removed during surgery to better visualize the tumor margins. The goal is to see if this imaging method can help confirm complete tumor removal during surgery, potentially reducing the need for additional treatments, shortening treatment times, and lowering emotional stress and costs for patients. This is an exploratory pilot study including various tumor types such as breast, prostate, thyroid, skin, hepatobiliary, and others. Participants will receive a single intravenous injection of a radiotracer before surgery, with the type and dose adjusted based on their specific tumor group. After the tumor is removed, the specimen is scanned using a specialized high-resolution PET-CT scanner in the operating room. While no treatment decisions are generally made based on these images, the surgeon may decide to remove additional tissue if needed. The study also compares these images with standard preoperative imaging to assess visualization differences. During the study, participants will undergo surgery as part of their treatment, with the added PET-CT specimen imaging performed during the operation. Researchers will collect data on the correlation between imaging results and microscopic histopathological analysis of tumor margins up to two weeks after surgery. They will also compare the perioperative images with preoperative scans. This study includes assessments of radiation safety and aims to gather scientific knowledge on the clinical usefulness of this imaging technique across various tumor types. Participation duration depends on surgical and follow-up timelines, ending around two weeks after surgery when pathology results are reviewed.
CONDITIONS
Brief Title
High-resolution PET-CT Specimen Imaging for the Perioperative Visualization of Resection Margins
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to understand treatment protocol and informed consent form
- Estimated by the investigator to be compliant for study participation
- Confirmed breast cancer with indication for breast conserving surgery
- Confirmed prostate cancer with indication for prostatectomy surgery
- Confirmed thyroid lesion with indication for resective surgery
- Confirmed parathyroid adenoma with indication for resective surgery
- Suspected basal cell carcinoma, squamous cell carcinoma, or melanoma with indication for resective surgery
- Suspected lesion in genitourinary sites needing resective surgery
- Suspected lesion in head and neck region needing resective surgery
- Confirmed primary or secondary hepatobiliary cancer needing resective surgery
- Patients undergoing biopsy after metabolic active lesions detected on PET scan
- Suspected neuro-endocrine malignancies with indication for resective surgery
- Suspected brain tumor with indication for resective surgery
- Suspected malignant and benign gastrointestinal lesions needing resective surgery
- Suspected malignant thoracovascular lesions needing resective surgery
You will not qualify if you...
- General or local contraindications for resective surgery
- Blood glucose level over 200 mg/dL on day of surgery if FDG-based PET tracers are used
- Pregnancy or lactation
- Participation in other clinical studies with radiation exposure over 1 mSv in the past year
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 5 hours on the day of surgery
Participants receive a single intravenous injection of a radiotracer between 30 minutes and 5 hours before surgery. Blood glucose levels are measured if 18F-FDG is used. The type and dose of radiotracer depends on the participant's cancer type or lesion.
1 visit (in-person)
Duration - Day of surgery
During surgery, the resected specimen is imaged in the operation theatre using a high-resolution PET-CT specimen imager. Additional tissue may also be imaged. Treatment decisions are primarily based on standard care but may be adjusted at the surgeon's discretion based on specimen imaging.
1 surgical visit (in-person)
Duration - Up to 2 weeks after surgery
Participants are monitored up to 2 weeks after surgery to assess histopathology results and correlate margin status.
1 to 2 visits (in-person)
Trial Site Locations
Total: 1 location
1
AZ Maria Middelares
Ghent, Oost Vlaanderen, Belgium, 9000
Actively Recruiting
Research Team
T
Tessa Van Oostveldt
S
Steffi Ryckaert
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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