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NCT Number: NCT06676943

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospitals Coventry and Warwickshire NHS Trust

Coventry, CV2 2DX, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

For prostate cancer patients:

  • General or local contra-indications for resectional surgery.
  • Lacks capacity to provide informed consent.
  • 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:

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

Treatment and study plan

XEOS AURA 10 specimen PET-CT scan of tumour specimens

Procedure

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.

Primary outcomes

  1. To assess the accuracy of intra-operative high-resolution surgical specimen PET-CT (XEOS Aura 10) in determining margin status during prostate cancer resection, and head and neck cancer resection specimens compared to the reference gold standard.

    Time frame: Up to 8 weeks after the day of surgery when the histopathological margin status result is recorded.

    The true gold standard is whether the cancer is on the margin (positive) or not (negative) as per specimen PET-CT compared to the gold standard radical prostatectomy histopathological margin status, and head and neck cancer resection specimen.

Sponsors and collaborators

Lead sponsor

University Hospitals Coventry and Warwickshire NHS Trust

Other

Registry information

Official study title

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

Acronym: eXcision

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 6, 2024
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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