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NCT06676943Completed

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

Source: ClinicalTrials.gov · Last updated 13 Apr 2026

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Interventional
Enrollment
57 (actual)
First submitted
31 Oct 2024
Start date
20 Sept 2024
Primary completion date
28 Aug 2025
Lead sponsor
University Hospitals Coventry and Warwickshire NHS Trust
NCT number
NCT06676943

What you commit to

  • Study type: Interventional
  • Participants enrolled: 57
  • From 20 Sept 2024 to the primary completion date, 28 Aug 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • General or local contra-indications for resectional surgery.
  • General or local contra-indications for resectional surgery.

Other illness

  • For prostate cancer patients:
  • Currently participating in another interventional research study that in the judgment of the investigator would negatively affect the participant and/or this study's data integrity.
    • For head and neck cancer patients:

Other

  • Lacks capacity to provide informed consent.
  • Lacks capacity to provide informed consent.
  • Pregnant or breast feeding patient.
  • Currently participating in another interventional research study that in the judgment of the investigator would negatively affect the participant and/or this study's data integrity.

Who the study is looking for

  • For prostate cancer patients:
  • At least 18 years old at time of consent.
  • Listed for Robotic Radical Prostatectomy.
    • For head and neck cancer patients:
  • At least 18 years old at time of consent.
  • Listed for resection of oral squamous cell carcinoma head and neck cancer resection.
  • Specimen able to fit into Xeos Aura specimen container.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University Hospitals Coventry and Warwickshire NHS Trust
Coordinator of this site? Confirm its status
CoventryUnited KingdomUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.