Magnetomotoric Ultrasound (MMUS) in Rectal Cancer (MAMORECT)

Magnetomotoric Ultrasound (MMUS) in the Staging of Rectal Cancer

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

Study Overview

• Status: Recruiting
• Conditions: Rectal Cancer
• Intervention / Treatment: Diagnostic test: Magnetomotoric ultrasound

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 Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Carl-Fredrik Rönnow, MD, PhD; Phone Number: +4640-331635; Email: carl-fredrik.ronnow@med.lu.se
• Study Contact Backup: Name: Henrik Thorlacius, Professor; Phone Number: +46 40-331000; Email: henrik.thorlacius@med.lu.se

Study Locations

• Sweden
  • Skåne
    • Malmö, Skåne, Sweden, 20501
      • Recruiting
      • Skane University Hospital, Malmö, section of Surgery
      • Contact: Henrik Thorlacius, Professor; Phone Number: +46 40-331000; Email: henrik.thorlacius@med.lu.se
      • Contact: Carl-Fredrik Rönnow, MD, PhD; Phone Number: +46 40-331635; Email: carl-fredrik.ronnow@med.lu.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Not able to give informed consent
• Synchronus colorectal cancer

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Magnetomotoric ultrasound; Magnetomotoric ultrasound in addition to MRI.	Diagnostic test: Magnetomotoric ultrasound; Nanoparticles will be injected close to the tumor. Magnetomotoric ultrasound will be performed just before scheduled standard operation, when the patient is anesthetized.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Accuracy of mesorectal lymph node diagnosis with MMUS, compared with final histopathology	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)	Approximately 1 hour after MMUS
Accuracy of mesorectal lymph node diagnosis with MMUS, compared with preoperative MRI	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.	Approximately 1 hour after MMUS

Collaborators and Investigators

• Sponsor: Region Skane

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2022
• Primary Completion (Estimated): December 20, 2024
• Study Completion (Estimated): January 1, 2025

Study Registration Dates

• First Submitted: September 6, 2021
• First Submitted That Met QC Criteria: September 21, 2021
• First Posted (Actual): September 22, 2021

Study Record Updates

• Last Update Posted (Actual): April 23, 2024
• Last Update Submitted That Met QC Criteria: April 22, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Rectal Neoplasms
• Other Study ID Numbers: MAMORECT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No