MAMORECT: Magnetomotoric Ultrasound (MMUS) in Rectal Cancer

Sponsor

Region Skane (Other)

Overall Status

Recruiting

CT.gov ID

NCT05052086

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

3.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Rectal Cancer	Diagnostic Test: Magnetomotoric ultrasound	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

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.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.

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

Magnetomotoric Ultrasound (MMUS) in the Staging of Rectal Cancer

Anticipated Study Start Date :

Oct 1, 2021

Anticipated Primary Completion Date :

Dec 20, 2022

Anticipated Study Completion Date :

Mar 1, 2023

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Rectal cancer
Scheduled for total mesorectal surgery
Informed consent

Exclusion Criteria:

Not able to give informed consent
Synchronus colorectal cancer

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Skane University Hospital, Malmö, section of Surgery	Malmö	Skåne	Sweden	20501

Sponsors and Collaborators

Region Skane

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Region Skane

ClinicalTrials.gov Identifier:

NCT05052086

Other Study ID Numbers:

MAMORECT

First Posted:

Sep 22, 2021

Last Update Posted:

Sep 22, 2021

Last Verified:

Sep 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Rectal Neoplasms

Study Results

No Results Posted as of Sep 22, 2021