Magnetomotoric Ultrasound for Diagnostic Purposes in Rectal Cancer (MMURC)

December 7, 2023 updated by: Eva Angenete, Sahlgrenska University Hospital, Sweden
A magnetomotive ultrasound combines standard diagnostic ultrasound equipment with the application of an external time-varying magnetic field. The investigators aim to use this equipment to improve preoperative diagnostics in rectal cancer.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The investigators will compare magnetomotive ultrasound with MRI and pathology report on specimens extracted during surgery.

Study Type

Observational

Enrollment (Estimated)

28

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

Study Locations

  • Sweden
      • Gothenburg, Sweden, SE 416 85
        • Recruiting
        • Dept. of Surgery, Sahlgrenska University Hospital/Ostra
        • Contact:
          • Erik
        • 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

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Patients with rectal cancer undergoing abdominoperineal excision.

Description

Inclusion Criteria:

  • Rectal cancer
  • Surgery with abdominoperineal resection

Exclusion Criteria:

  • No informed consent
  • Not fulfilling inclusion criteria
  • No rectal cancer

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with rectal cancer
Patients with rectal cancer will be included and asked to participate in the study where a MMUS will be used after resection to test diagnostic accuracy.
Diagnostic test: MMUS
MMUS will be used to perform diagnostics, we will compare with MRI and histology

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Accuracy of lymph node diagnosis compared to pathology report
Time Frame: 1 hour postoperatively
Accuracy of lymph node diagnosis - a comparison between the findings with the device and the pathology report
1 hour postoperatively
Accuracy of lymph node diagnosis compared to MRI
Time Frame: 1 hour postoperatively
Accuracy of lymph node diagnosis compared to MRI
1 hour postoperatively

Collaborators and Investigators

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

Sponsor

Sahlgrenska University Hospital, Sweden

Collaborators

Lund University

Investigators

  • Principal Investigator: Eva Angenete, Sahlgrenska Universitetssjukhuset

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)

June 17, 2021

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

October 23, 2020

First Submitted That Met QC Criteria

November 6, 2020

First Posted (Actual)

November 9, 2020

Study Record Updates

Last Update Posted (Actual)

December 8, 2023

Last Update Submitted That Met QC Criteria

December 7, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MMURC

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

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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