MMURC: Magnetomotoric Ultrasound for Diagnostic Purposes in Rectal Cancer

Sponsor

Sahlgrenska University Hospital, Sweden (Other)

Overall Status

Recruiting

CT.gov ID

NCT04622176

Collaborator

Lund University (Other)

Enrollment

Location

19.5

Anticipated Duration (Months)

1.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Rectal Cancer	Diagnostic Test: MMUS

Detailed Description

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

Study Design

Study Type:

Observational

Anticipated Enrollment :

28 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Magnetomotoric Ultrasound for Diagnostic Purposes in Rectal Cancer

Actual Study Start Date :

Jun 17, 2021

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Feb 1, 2023

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

Accuracy of lymph node diagnosis compared to pathology report [1 hour postoperatively]
Accuracy of lymph node diagnosis - a comparison between the findings with the device and the pathology report
Accuracy of lymph node diagnosis compared to MRI [1 hour postoperatively]
Accuracy of lymph node diagnosis compared to MRI

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Inclusion Criteria:

Rectal cancer
Surgery with abdominoperineal resection

Exclusion Criteria:

No informed consent
Not fulfilling inclusion criteria
No rectal cancer

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dept. of Surgery, Sahlgrenska University Hospital/Ostra	Gothenburg		Sweden	SE 416 85

Sponsors and Collaborators

Sahlgrenska University Hospital, Sweden
Lund University

Investigators

Principal Investigator: Eva Angenete, Sahlgrenska Universitetssjukhuset

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Eva Angenete, Professor of surgery, Sahlgrenska University Hospital, Sweden

ClinicalTrials.gov Identifier:

NCT04622176

Other Study ID Numbers:

MMURC

First Posted:

Nov 9, 2020

Last Update Posted:

Apr 14, 2022

Last Verified:

Apr 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Rectal Neoplasms

Study Results

No Results Posted as of Apr 14, 2022