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

Algemeen Ziekenhuis Maria Middelares

Status: Enrolling

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

Treatments: Other: Single intravenous injection of the radiotracer; Diagnostic Test: Imaging resected specimen using the high-resolution PET-CT specimen imager

Study type: Interventional

Funder types: Other

Identifiers

NCT06835426

MMS.2022.048

B0172022000009 (Registry Identifier)

Details and patient eligibility

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.

Full description

The rationale of this pilot study is to obtain scientific knowledge on the clinical usefulness of perioperative high-resolution PET-CT specimen imaging in different clinical indications and to document the radiation safety of perioperative high-resolution PET-CT specimen imaging.

The study will investigate the clinical value of perioperative high-resolution PET-CT specimen imaging in breast, prostate, thyroid, head & neck, skin, and primary and secondary hepatobiliary cancer, parathyroid adenoma, brain cancer, suspected malignant and benign gastrointestinal lesions, neuro-endocrine malignancies, genitourinary malignancies (including bladder cancer, renal pelvis and ureter carcinoma, adrenal cortical carcinoma and renal cell carcinoma), thoracovascular malignancies and in patients undergoing biopsy after metabolic active lesions were detected.

The secondary objectives of the study are:

• to correlate the margin status based on high-resolution PET-CT specimen images with the margin status based on microscopic histopathological analysis;
• to compare the visualization of the target lesion between perioperative high-resolution PET-CT specimen imaging and pre-operative standard-of-care imaging (e.g. whole-body PET-CT imaging, MRI imaging etc);

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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150 participants in 1 patient group

Single arm

Experimental group

Description:

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:

Diagnostic Test: Imaging resected specimen using the high-resolution PET-CT specimen imager

Other: Single intravenous injection of the radiotracer