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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAlgemeen Ziekenhuis Maria Middelares

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

able to understand treatment protocol and informed consent form

estimated by the investigator to be compliant for study participation

confirmed breast cancer with an indication to undergo breast conserving surgery

confirmed prostate cancer with an indication to undergo resective surgeryprostatectomy;

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • Single intravenous injection of the radiotracer

    Other intervention

    * 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

  • Imaging resected specimen using the high-resolution PET-CT specimen imager

    Diagnostic test

    * 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;

Treatment groups

150 Participants
are divided into 1 treatment group
Group A: Single armExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Correlation of margin status

to correlate the margin status based on high-resolution PET-CT specimen images with the margin status based on microscopic histopathological analysis

Time frame
Up to 2 weeks after surgery (histopathology results)

Secondary outcomes

1

Comparison of the visualization of the target lesion

post-hoc comparison of the visualization of the target lesion between perioperative high-resolution PET-CT specimen imaging and pre-operative standard-of-care imaging (if recent pre-operative scan available). This will include lesion dimensions (e.g. delineation based on percentage of SUVmax) but also tumor to background ratio variability;

Time frame
From pre-operative imaging until imaging during surgery

Other outcomes

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