Magnetomotoric Ultrasound (MMUS) in Rectal Cancer

Not Applicable

Recruiting

• Conditions: Rectal Cancer
• Interventions: Diagnostic Test: Magnetomotoric ultrasound

• Registration Number: NCT05052086
• Lead Sponsor: Region Skane

Brief Summary

Magnetomotoric ultrasound, combines conventional ultrasound with a time-varying magnetic field. The aim is to improve diagnosis of mesolectal lymph nodes.

Detailed Description

Magnetomotoric ultrasound, combines conventional ultrasound with a time-varying magnetic field. Nanoparticles are injected close to the rectal cancer and migrate to adjacent lymph nodes.The time-varying magnetic field will influence the nano particles in the lymph node enhancing diagnosis of affected lymph nodes. The aim is to improve diagnosis of mesolectal lymph nodes and compare the results of magnetomotoric ultrasound with MRI and final histopathology.

Study Timeline

• Study First Submitted: 2021-09-06
• Study First Submitted QC: 2021-09-21
• Study First Posted: 2021-09-22
• Study Start: 2022-11-01
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-22
• Last Update Posted: 2024-04-23
• Primary Completion: 2024-12-20
• Study Completion: 2025-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Rectal cancer
• Scheduled for total mesorectal surgery
• Informed consent

Exclusion Criteria

• Not able to give informed consent
• Synchronus colorectal cancer

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Magnetomotoric ultrasound	Magnetomotoric ultrasound	Magnetomotoric ultrasound in addition to MRI.

Primary Outcome Measures

Name	Time	Method
Accuracy of mesorectal lymph node diagnosis with MMUS, compared with final histopathology	Approximately 1 hour after MMUS	Evaluation of the accuracy of MMUS in detecting lymph node metastases in rectal cancer. The results of the MMUS (malignant or benign lymph nodes) will be compared with final histopathology. The accuracy will be expressed in sensitivity (%), specificity (%) and overall accuracy (% correctly staged lymph nodes with MMUS)
Accuracy of mesorectal lymph node diagnosis with MMUS, compared with preoperative MRI	Approximately 1 hour after MMUS	Evaluation of the accuracy of MMUS in detecting lymph node metastases in rectal cancer in comparison to standard staging (MRI). The results of the MMUS (malignant nodes or benign nodes) will be compared with the results of preoperative MRI (malignant or benign lymph nodes) and the final histopathology. The accuracy will be expressed in sensitivity (%), specificity (%) and overall accuracy (% correctly staged lymph nodes) with MMUS and MRI.

Trial Locations

Locations (1)

Skane University Hospital, Malmö, section of Surgery; 🇸🇪 Malmö, Skåne, Sweden