Magnetomotoric Ultrasound (MMUS) in Rectal Cancer

NCT05052086 | Recruiting

• 1 other identifier: MAMORECT
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Rectal Cancer

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

Magnetomotoric ultrasound

EXPERIMENTAL

Magnetomotoric ultrasound in addition to MRI.

Diagnostic Test: Magnetomotoric ultrasound

Interventions

Magnetomotoric ultrasound DIAGNOSTIC_TEST

Nanoparticles will be injected close to the tumor. Magnetomotoric ultrasound will be performed just before scheduled standard operation, when the patient is anesthetized.

Magnetomotoric ultrasound

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Not able to give informed consent
• Synchronus colorectal cancer

Sponsors & Collaborators

• Region Skane: lead

Study Sites (1)

Skane University Hospital, Malmö, section of Surgery

Malmo, Skåne County, 20501, Sweden

RECRUITING

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Central Study Contacts

Carl-Fredrik Rönnow, MD, PhD

CONTACT

+4640-331635; carl-fredrik.ronnow@med.lu.se

Henrik Thorlacius, Professor

CONTACT

+46 40-331000; henrik.thorlacius@med.lu.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Included patients will undergo magnetomotoric ultrasound in addition to conventional MRI. The results of MRI examination and magnetomotoric ultrasound will be compared with final histopathology.

Study Record Dates

• First Submitted: September 6, 2021
• First Posted: September 22, 2021
• Study Start: November 1, 2022
• Primary Completion: December 20, 2024
• Study Completion: January 1, 2025
• Last Updated: April 23, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)