Magnetomotoric Ultrasound (MMUS) in Rectal Cancer

Rectal Cancer Clinical Trial

— MAMORECT  

Official title:

Magnetomotoric Ultrasound (MMUS) in the Staging of Rectal Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05052086
• Other study ID #: MAMORECT
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2022
• Est. completion date: January 1, 2025

Study information

• Verified date: April 2024
• Source: Region Skane
• Contact: Carl-Fredrik Rönnow, MD, PhD
• Phone: +4640-331635
• Email: carl-fredrik.ronnow[@]med.lu.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: January 1, 2025
• Est. primary completion date: December 20, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Not able to give informed consent
• Synchronus colorectal cancer

Related Conditions & MeSH terms

• Rectal Cancer
• Rectal Neoplasms

Intervention

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.

Locations

Country	Name	City	State
Sweden	Skane University Hospital, Malmö, section of Surgery	Malmö	Skåne

Sponsors (1)

Lead Sponsor	Collaborator
Region Skane

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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