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

RecruitingNAAges 18 Years - anyAllAlgemeen Ziekenhuis Maria Middelares
NCT06835426 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
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.
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What it tests

  • Single intravenous injection of the radiotracer
  • Imaging resected specimen using the high-resolution PET-CT specimen imager
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Where

1 site
AZ Maria Middelares
Ghent, Belgium
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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