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

Sponsor
Algemeen Ziekenhuis Maria Middelares
Study ID
NCT06835426
Status
Recruiting
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Conditions

  • Brain Tumours
  • Breast Carcinoma
  • Gastro Intestinal Cancer
  • Genitourinary Cancer
  • Head and Neck Cancer
  • Hepatobiliary Cancers
  • Metabolic Abnormality
  • Neuro Endocrine Tumours
  • Parathyroid Adenomas
  • Prostate Cancer Surgery
  • Skin Cancer
  • Thoracoscopic Surgery
  • Thyroid Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Single intravenous injection of the radiotracer — OTHER
    * 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;

Study Details

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.

Key Dates

First listed
Feb 19, 2025
Start date
Aug 6, 2023
Status verified
Feb 2025
Primary completion
Jan 30, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
150 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Single arm
    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.

Primary Outcome Measure

Correlation of margin status [ Time Frame: Up to 2 weeks after surgery (histopathology results) ]

Central Contacts

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