RecruitingNot ApplicableNCT06676943

Investigating the Diagnostic Performance of High-resolution Specimen PET-CT in Determining Margin Status in Cancer Resection

A Single Centre Pilot Study Investigating the Diagnostic Performance of High-resolution Specimen PET-CT in Determining Margin Status in Cancer Resection


Sponsor

University Hospitals Coventry and Warwickshire NHS Trust

Enrollment

87 participants

Start Date

Sep 20, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

Surgical removal is the treatment for many different cancers. Patient outcomes depend on complete cancer removal with no tumour present at the edge of the section removed (specimen). If cancer is left behind, then patients might need additional cancer treatment. Regardless of whether extra treatment is required, knowing that removal was incomplete causes anxiety. The need for a wide removal of the tumour must be balanced against the harm caused by more extensive surgery particularly when important organs and structures are close by. The fact that the cancer is not visible to the surgeon during the operation means that there is an element of guesswork when deciding how much tissue to remove. This study is examining a technique that the investigators hope will provide surgeons with more precise information about how much tissue to remove during cancer operations using a new type of Positron Emission Tomography-Computed Tomography (PET-CT) scanner. Patients with different types of cancer (e.g. prostate, head and neck cancer) will be injected with a small amount of radioactive tracer at the beginning of their cancer operation. This tracer will attach itself to the cancer cells. Once the surgical specimen is removed it will be placed into the specimen PET-CT scanner so that the surgeon can see the cancer within the specimen. The investigators will then compare the results of the scan of the specimen taken during the operation with the results when the whole specimen has been examined under the microscope. Examination under the microscope is considered to be the gold standard for deciding whether the cancer removal operation has been successful. This study aims to tell us how accurate the new specimen PET-CT scanner results are, and so whether or not surgeons can rely on the results to guide them during operations in the future.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study investigates whether a specialized high-resolution PET-CT scanner — used directly on the removed surgical specimen while still in the operating room — can quickly and accurately detect whether cancer was fully removed (clear margins) during surgery for prostate, oral, or head and neck cancer. **You may be eligible if...** - You are 18 or older - You have prostate cancer scheduled for robotic radical prostatectomy, OR - You have oral or head and neck squamous cell cancer scheduled for surgical removal - You consent to have your removed tissue scanned immediately after surgery **You may NOT be eligible if...** - You are under 18 - You have another cancer type not covered by this study - You are not scheduled for the relevant surgery at the study site Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREXEOS AURA 10 specimen PET-CT scan of tumour specimens

Participants will be injected with a small amount of radioactive tracer at the beginning of their cancer operation. This tracer will attach itself to the cancer cells. Once the surgical specimen is removed it will be placed into the specimen PET-CT scanner so that the surgeon can see the cancer within the specimen and assess the margin.


Locations(1)

University Hospitals Coventry and Warwickshire NHS Trust

Coventry, United Kingdom

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NCT06676943


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