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

  • Recruiting
  • Diagnostic
  • Interventional
  • Procedure
  • University Hospitals Coventry and Warwickshire NHS Trust
  • 18 Years -


Study Purpose

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.

Intervention

Procedure : XEOS AURA 10 specimen PET-CT scan of tumour specimens


Eligibility Requirements

info icon For prostate cancer patients:

info icon At least 18 years old at time of consent.

info icon Listed for Robotic Radical Prostatectomy.

info icon For head and neck cancer patients:

info icon At least 18 years old at time of consent.

info icon Listed for resection of oral squamous cell carcinoma head and neck cancer resection.

info icon Specimen able to fit into Xeos Aura specimen container.

info icon Minimum age: 18

info icon For prostate cancer patients:

info icon General or local contra-indications for resectional surgery.

info icon Lacks capacity to provide informed consent.

info icon Currently participating in another interventional research study.

info icon For head and neck cancer patients:

info icon General or local contra-indications for resectional surgery.

info icon Lacks capacity to provide informed consent.

info icon Pregnant or breast feeding patient.

info icon Currently participating in another interventional research study.

Recruiting status

Recruiting

Estimated enrollment

87

 
Study start date

Sep 20, 2024

Study end date

Sep 30, 2025

Last updated

Mar 24, 2025

Primary purpose

Diagnostic

Design

Interventional

Intervention

Procedure

Study phase

NA

Allocation

Na

 

Sponsor:

University Hospitals Coventry and Warwickshire NHS Trust

Collaborator:

N/A

Investigator:

N/A

NCT06676943

Clinic Location Investigator Distance RECRUITING STATUS Contact