Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06835426

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

Led by Algemeen Ziekenhuis Maria Middelares · Updated on 2025-02-19

150

Participants Needed

1

Research Sites

203 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Able to understand the treatment protocol and informed consent form
  • Estimated by the investigator to comply with study participation
  • Confirmed breast cancer with planned breast conserving surgery
  • Confirmed prostate cancer with planned prostatectomy surgery
  • Confirmed thyroid lesion with planned resective surgery
  • Confirmed parathyroid adenoma with planned resective surgery
  • Suspected basal cell carcinoma, squamous cell carcinoma, or melanoma with planned resective surgery
  • Suspected lesion in genitourinary sites requiring resective surgery
  • Suspected lesion in head and neck region requiring resective surgery
  • Confirmed primary or secondary hepatobiliary cancer requiring resective surgery
  • Patients undergoing biopsy after metabolically active lesions detected on PET scan
  • Suspected neuro-endocrine malignancies requiring resective surgery
  • Suspected brain tumor requiring resective surgery
  • Suspected malignant or benign gastrointestinal lesions requiring resective surgery
  • Suspected malignant thoracovascular lesions requiring resective surgery
Not Eligible

You will not qualify if you...

  • General or local contraindications for resective surgery
  • Blood glucose level over 200 mg/dL on the day of surgery if using FDG-based PET tracers
  • Pregnancy or lactation
  • Participation in other clinical studies with radiation exposure over 1 mSv in the past year

AI-Screening

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Trial Site Locations

Total: 1 location

1

AZ Maria Middelares

Ghent, Oost Vlaanderen, Belgium, 9000

Actively Recruiting

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Research Team

T

Tessa Van Oostveldt

CONTACT

S

Steffi Ryckaert

CONTACT

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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