Quantitative Margin Assessment Using High-resolution Positron Emission Tomography - Computed Tomograhy (qMAP)

December 9, 2024 updated by: University Medical Center Groningen
The primary endpoint is the assessment of the clinical value of a novel high-resolution mobile PET-CT scanner for intraoperative margin assessment in oral squamous cell carcinoma, soft tissue sarcoma and osteosarcoma surgery. The predicted margin status will be correlated with the margin status determined with histopathology.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

The ideal outcome in oncological surgery is resection of all tumor tissue with a margin of healthy tissue. However, positive surgical margins (PSMs) occur in up to 35% of the cases, depending on tumor type. The final margin status is only available five to seven days after surgery so that in case of a PSM, intensive adjuvant radiotherapy or chemotherapy is necessary. Despite adjuvant treatment, patients still have a significantly reduced overall survival. Therefore, the intraoperative identification of PSMs is paramount to enable surgical corrections and obtain a complete resection.

The investigators propose a dedicated intraoperative high-resolution PET-CT (positron emission tomography - computed tomography) imaging system for margin assessment of the excised specimen. The proposed specimen imaging system would combine the proven functional imaging capabilities of PET with the anatomical imaging info of CT, providing multi-modal information to determine whether tumor cells are present at the excision edges of the specimen. The tomographic images obtained can precisely demonstrate tumor extension along the x, y, and z axis, and the PET signal is not distorted by bone tissue. PET is the most sensitive medical imaging modality capable of detecting the picomolar concentrations of radiotracer, allowing to assess the presence of tumor cells within the specimen margins with high precision. Current standard PET-CT scanners have a spatial resolution between 3mm and 6mm, which is insufficient to accurately assess the excision margins of tumors. A specimen imaging system ideally should have a sub-millimeter resolution. The specimen PET system which will be used in this study is capable of this. The potential of intraoperative PET-CT has been shown in several tumor types, enabling the intraoperative identification of PSMs in prostatectomy and lumpectomy specimens.

Study Type

Interventional

Enrollment (Estimated)

30

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 Contact

  • Name: Jasper Vonk, Dr.
  • Phone Number: +31 50 36162029
  • Email: j.vonk@umcg.nl

Study Locations

  • Netherlands
      • Groningen, Netherlands, 9713 GZ
        • University Medical Center Groningen
        • Contact:
        • Contact:

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:

  • Age ≥18 years.
  • Patient is confirmed with oral squamous cell carcinoma, soft tissue sarcoma or osteosarcoma.
  • Patient is indicated to undergo curative surgery of the primary tumor.
  • Patient is estimated compliant for study participation by the investigator.
  • Written informed consent.

Exclusion Criteria:

  • Medical or psychiatric conditions that compromise the patient's ability to give informed consent;
  • Patient has previously received radiotherapy of the primary tumor region;
  • Patient has participated in other clinical studies with radiation exposure of more than 1 mSv in the past 12 months;
  • A blood glucose level over 200 mg/dL on the day of surgery.
  • Pregnancy or lactation.

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
Other: 2 MBq 18F-FDG
Subjects are intravenously administered with 2.0 MBq/kg 18F-FDG, standard tracer used to diagnose and stage the malignancy. After standard of care excision of the primary tumor, a high-resolution PET-CT imaging of the fresh surgical specimen will be performed.
Device: XEOS AURA 10
Surgery is performed according to standard of care. Directly after surgery, the surgical specimen is taken outside the operation theatre in a dedicated imaging room at the Department of Nuclear Medicine where high-resolution PET-CT imaging of the surgical specimen is performed.
Other Names:
  • PET
  • PET/CT
  • High resolution PET/CT
  • Margin detection
  • Margin status

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The primary endpoint is to determine the margin detection rates of a novel high-resolution mobile PET-CT for intraoperative margin assessment in OSCC, STS, and OS surgery.
Time Frame: Postoperatively i.e. 7-10 working days
Tumor positive and negative margin detection rates of the novel high-resolution mobile PET-CT scanner compared to standard of care pathology.
Postoperatively i.e. 7-10 working days

Collaborators and Investigators

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

Sponsor

University Medical Center Groningen

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 (Estimated)

January 1, 2025

Primary Completion (Estimated)

October 1, 2025

Study Completion (Estimated)

April 1, 2026

Study Registration Dates

First Submitted

October 16, 2024

First Submitted That Met QC Criteria

December 9, 2024

First Posted (Estimated)

December 10, 2024

Study Record Updates

Last Update Posted (Estimated)

December 10, 2024

Last Update Submitted That Met QC Criteria

December 9, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NL86142.042.24

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Relevant research data on request

IPD Sharing Time Frame

It will be available after the end date of the study. It will be available for 15 years after the study has ended.

IPD Sharing Access Criteria

PI and other researchers on request. They are able to access the Study Protocol and the Clinical Study Report

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • CSR

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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