Magnetomotoric Ultrasound for Diagnostic Purposes in Rectal Cancer

Recruiting

• Conditions: Rectal Cancer
• Interventions: Diagnostic Test: MMUS

• Registration Number: NCT04622176
• Lead Sponsor: Sahlgrenska University Hospital, Sweden

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.

Detailed Description

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

Study Timeline

• Study First Submitted: 2020-10-23
• Study First Submitted QC: 2020-11-06
• Study First Posted: 2020-11-09
• Study Start: 2021-06-17
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-07
• Last Update Posted: 2023-12-08
• Primary Completion: 2024-12-31
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

• Rectal cancer
• Surgery with abdominoperineal resection

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with rectal cancer	MMUS	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.

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Dept. of Surgery, Sahlgrenska University Hospital/Ostra; 🇸🇪 Gothenburg, Sweden