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

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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

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.

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 Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06835426
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Algemeen Ziekenhuis Maria Middelares
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	Belgium
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Breast Carcinoma, Prostate Cancer Surgery, Thyroid Cancer, Parathyroid Adenomas, Skin Cancer, Genitourinary Cancer, Head and Neck Cancer, Hepatobiliary Cancers, Metabolic Abnormality, Neuro Endocrine Tumours, Brain Tumours, Gastro Intestinal Cancer, Thoracoscopic Surgery

Additional Details

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);

Arms & Interventions

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.

Interventions

Other: - Single intravenous injection of the radiotracer

- 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

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

- 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;

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