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

NCT06676943 | Completed

• 1 other identifier: OA641624
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Prostate Cancer Surgery; Head and Neck Cancers

Keywords

specimen PET-CT; surgical margin status

Outcome Measures

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.

  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.

Study Arms (1)

Radical prostatectomy and Head and neck specimens

EXPERIMENTAL

Patients undergoing surgical resection for prostate cancer or head and neck cancer.

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

Interventions

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.

Radical prostatectomy and Head and neck specimens

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospitals Coventry and Warwickshire NHS Trust: lead

Study Sites (1)

University Hospitals Coventry and Warwickshire NHS Trust

Coventry, CV2 2DX, United Kingdom

Location

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2024
• First Posted: November 6, 2024
• Study Start: September 20, 2024
• Primary Completion: August 28, 2025
• Study Completion: August 28, 2025
• Last Updated: April 13, 2026

Record last verified: 2025-02

Locations

GB (1)