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

Launched by ALGEMEEN ZIEKENHUIS MARIA MIDDELARES · Feb 14, 2025

Keywords

ClinConnect Summary

This clinical trial is exploring a new imaging technique called high-resolution PET-CT to help surgeons ensure that they completely remove tumors during surgery. When a tumor is removed, it is usually examined under a microscope afterward to check if any cancerous tissue is left behind. This process can take several days, which might mean that patients need more treatments if any cancer is found. The goal of this study is to see if using PET-CT imaging on the removed tissue right away can provide quicker answers, allowing for any necessary additional tissue removal during the same surgery. This could lead to less stress for patients and potentially shorter overall treatment times.

To participate in this trial, patients should be between 65 and 74 years old and have specific types of cancers, such as breast, prostate, or thyroid cancer, among others. They need to be able to understand the study and give their consent. Importantly, those with certain medical conditions or high blood sugar levels on surgery day will not be eligible. If you join the study, you'll receive a small amount of a radioactive tracer before surgery, which helps the PET-CT scanner see the tumor tissue more clearly after it has been removed. This could help improve surgical outcomes and reduce the need for extra treatments later on.

Gender

ALL

Eligibility criteria

• A. Inclusion Criteria:
• • able to understand treatment protocol and informed consent form
• • estimated by the investigator to be compliant for study participation
• 1. Fulfilling all group-specific inclusion criteria:
• • confirmed breast cancer with an indication to undergo breast conserving surgery
• • confirmed prostate cancer with an indication to undergo resective surgeryprostatectomy;
• • confirmed thyroid lesion with an indication to undergo resective surgery;
• • confirmed parathyroid adenoma with an indication to undergo resective surgery;
• • suspected basal cell carcinoma, squamous cell carcinoma or melanoma with an indication to undergo resective surgery;
• • suspected lesion in genitourinary sites (including bladder cancer, renal pelvis and ureter carcinoma, adrenal cortical carcinoma and renal cell carcinoma) with an indication to undergo resective surgery;
• • suspected lesion in the head \& neck region with an indication to undergo resective surgery;
• • confirmed primary or secondary hepatobiliary cancer with an indication to undergo resective surgery;
• • patients undergoing biopsy after metabolic active lesions were detected on a PET scan.
• • suspected neuro-endocrine malignancies with an indication to undergo resective surgery.
• • suspected brain tumor with an indication to undergo resective surgery.
• • Suspected malignant and benign gastrointestinal lesions with an indication to undergo resective surgery.
• • suspected malignant thoracovascular lesions with an indication to undergo resective surgery
• B. Exclusion Criteria:
• • general or local contra-indications for resective surgery;
• • in case of FDG-based PET tracers: a blood glucose level over 200 mg/dL on the day of surgery;
• • pregnancy or lactation;
• • participation in other clinical studies with a radiation exposure of more than 1 mSv in the past year.