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

April 9, 2026 updated by: University Hospitals Coventry and Warwickshire NHS Trust

A Single Centre Pilot Study 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

57

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Coventry, United Kingdom, CV2 2DX
        • University Hospitals Coventry and Warwickshire NHS Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

For prostate cancer patients:

  1. At least 18 years old at time of consent.
  2. Listed for Robotic Radical Prostatectomy.

For head and neck cancer patients:

  1. At least 18 years old at time of consent.
  2. Listed for resection of oral squamous cell carcinoma head and neck cancer resection.
  3. Specimen able to fit into Xeos Aura specimen container.

Exclusion Criteria:

For prostate cancer patients:

  1. General or local contra-indications for resectional surgery.
  2. Lacks capacity to provide informed consent.
  3. 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:

  1. General or local contra-indications for resectional surgery.
  2. Lacks capacity to provide informed consent.
  3. Pregnant or breast feeding patient.
  4. 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Radical prostatectomy and Head and neck specimens
Patients undergoing surgical resection for prostate cancer or head and neck cancer.
Procedure: XEOS 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 8 weeks after the day of surgery when the histopathological margin status result is recorded.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospitals Coventry and Warwickshire NHS Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 20, 2024

Primary Completion (Actual)

August 28, 2025

Study Completion (Actual)

August 28, 2025

Study Registration Dates

First Submitted

October 31, 2024

First Submitted That Met QC Criteria

November 4, 2024

First Posted (Actual)

November 6, 2024

Study Record Updates

Last Update Posted (Actual)

April 13, 2026

Last Update Submitted That Met QC Criteria

April 9, 2026

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OA641624

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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