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High-resolution PET-CT Specimen Imaging for the Perioperative Visualization of Resection Margins
Sponsor: Algemeen Ziekenhuis Maria Middelares
Summary
These are patients in whom a benign or malignant tumor was recorded requiring surgery. During that surgery, the surgeon will cut away the tumor as part of the treatment of the disease. In this process, it is important that the tumor is removed correctly and completely. To verify that the correct tissue was completely removed, the tissue is examined microscopically. However, a microscopic analysis takes a relatively long time and the result is not known until a few days after the surgery is completed. If that microscopic analysis should eventually reveal that the tumor was not completely removed, additional treatment is usually necessary. An assessment of the excised tissue during surgery would allow additional tissue to be excised in the same operation if necessary. Thus, in this way, additional treatments can also be avoided. This could lead to shorter treatment time and less emotional strain for the patient, as well as lower costs. To date, however, there are no effective techniques to do this. PositronEmissionTomography (PET) imaging can be used to image the tumor that needs to be excised. To do this, a tracer must be administered through the blood before the operation. This tracer is a slightly radioactive substance that can be detected by the PET camera even at low concentrations. This technique is already routinely used in the hospital to detect cancer or inflammatory tissue in the body. During this study, however, it's not the intention to look at the tumor while it is still in the patient's body, but rather after it has been cut out of the patient's body by the surgeon. To do this, the piece of tissue cut away will be scanned using a specially designed PET-CT scanner. The overall goal of this study is to gain additional knowledge. More specifically, the investigators wish to determine which medical conditions may benefit from high-resolution PET-CT specimen imaging.
Official title: High-resolution PET-CT Specimen Imaging for the Perioperative Visualization of Resection Margins: an Exploratory Pilot Study
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
150
Start Date
2023-08-06
Completion Date
2027-06-30
Last Updated
2025-02-19
Healthy Volunteers
No
Conditions
Interventions
Single intravenous injection of the radiotracer
* only in case of 18F-FDG as PET-tracer: blood glucose level is measured; * single intravenous injection of the radiotracer between 30 minutes and 5 hours (ideally between 60 and 90 minutes) before the specimen is imaged. The type and dose of radiotracer depends on the patient group: * breast cancer group: 0.8 MBq/kg of 18F-FDG * prostate cancer group: 1 MBq/kg 18F-PSMA * thyroid cancer group: 1 MBq/kg of 18F-FDG * parathyroid adenoma group: 1 MBq/kg of 18F-Choline * head \& neck cancer group: 1 MBq/kg of 18F-FDG * skin cancer group: 4 MBq/kg of 18F-FDG * primary and secondary hepatobiliary tumors group: 1 MBq/kg of 18F-FDG * genitourinary malignancies group: 1 MBq/kg of 18F-FDG * metabolic active lesions undergoing biopsy: 1 MBq/kg of 18F-FDG * Neuro-endocrine malignancies group: 1 MBq/kg of 18F-FDG * Brain tumor group: 1 MBq/kg of 18F-FDG, 18F-Choline or 18F * Gastrointestinal group: 1 MBq/kg of 18F-FDG * Thoracovascular group: 1MBq/kg of 18F-FDG
Imaging resected specimen using the high-resolution PET-CT specimen imager
* the resected specimen is imaged in the operation theatre using the high-resolution PET-CT specimen imager (XEOS Aura; XEOS Medical, Ghent, Belgium); in principle no treatment decisions will be taken based on the images acquired by the specimen imager; however a decision to extend the resection can be taken at the discretion of the surgeon if there is clinical suspicion of a positive resection margin; * additional resected tissue (e.g. lymph nodes, cavity shaves etc) could also be imaged by the high-resolution PET-CT specimen imager; no treatment decisions will be taken based on the images acquired by the specimen imager;
Locations (1)
AZ Maria Middelares
Ghent, Oost Vlaanderen, Belgium