High-resolution PET-CT Specimen Imaging for the Perioperative Visualization of Resection Margins

NARecruitingINTERVENTIONAL
Enrollment

150

Participants

Timeline

Start Date

August 6, 2023

Primary Completion Date

January 30, 2027

Study Completion Date

June 30, 2027

Conditions
Breast CarcinomaProstate Cancer SurgeryThyroid CancerParathyroid AdenomasSkin CancerGenitourinary CancerHead and Neck CancerHepatobiliary CancersMetabolic AbnormalityNeuro Endocrine TumoursBrain TumoursGastro Intestinal CancerThoracoscopic Surgery
Interventions
OTHER

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"

DIAGNOSTIC_TEST

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;"

Trial Locations (1)

9000

RECRUITING

AZ Maria Middelares, Ghent

All Listed Sponsors
lead

Algemeen Ziekenhuis Maria Middelares

OTHER