Scanning Removed Tumor Tissue With PET-CT During Surgery
Tests a PET-CT scan of removed tumor tissue to check margins in adults having surgery.
Key facts
- Who runs it
- Algemeen Ziekenhuis Maria Middelares
- Where
- Ghent, BelgiumSee the site
- Trial code
- Registry title
- High-resolution PET-CT Specimen Imaging for the Perioperative Visualization of Resection Margins
- Status
- Recruiting
- People taking part
- 150 people, planned
- Started
- 6 Aug 2023
- Expected to end
- 30 Jun 2027
- Type of study
- Interventional
- Treatments tested
- Single intravenous injection of the radiotracer
- Imaging resected specimen using the high-resolution PET-CT specimen imager
- Record updated
- 19 February 2025
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults who need surgery to remove a tumour or a suspicious lesion. The removed tissue is scanned with a PET-CT scanner.
- Age
- 18 years or older.
- Sex
- All sexes can join.
- Disease stage
- A confirmed or suspected tumour or lesion that needs surgery to remove it. The sites named include breast, prostate, thyroid, parathyroid, skin, urinary and genital organs, head and neck, liver and bile ducts, nerve and hormone tumours, brain, gut and chest vessels. Also people having a biopsy after a PET scan showed an active lesion.
Main reasons for not taking part
- Any general or local reason that rules out removal surgery
- Blood sugar above 200 mg/dL (11.1 mmol/L) on the day of surgery, when an FDG-based PET tracer is used
- Pregnancy or breastfeeding
- Taking part in another study in the past year with radiation exposure of more than 1 mSv
- Being unable to understand the study and the consent form
The registry criteria, word for word
Show all 21 criteriaShow less
Other criteria
- Inclusion Criteria:
- able to understand treatment protocol and informed consent form
- estimated by the investigator to be compliant for study participation; 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
- 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
Where in Belgium
- AZ Maria MiddelaresGhent, BelgiumContact: Steffi Ryckaert, Clinical Research Centre ManagTaking people
About the trial
What the trial wants to find out
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.
Read full original descriptionShow less
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.
The group in the trial
- Single armTreatment being tested
This is a single-arm interventional pilot study. Patients eligable for this study who signed the Informed consent will be included and will follow the interventions as described.
Treatment: Single intravenous injection of the radiotracer and Imaging resected specimen using the high-resolution PET-CT specimen imager
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- High-resolution PET-CT Specimen Imaging for the Perioperative Visualization of Resection Margins: an Exploratory Pilot Study
- Plain-language title
- Scanning Removed Tumor Tissue With PET-CT During SurgeryGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 19 February 2025