Magnetomotoric Ultrasound (MMUS) in Rectal Cancer

NCT ID: NCT05052086

Last Updated: 2024-04-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-01

Study Completion Date

2025-01-01

Brief Summary

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

Detailed Description

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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.

Conditions

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Rectal Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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.
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Magnetomotoric ultrasound

Magnetomotoric ultrasound in addition to MRI.

Group Type EXPERIMENTAL

Magnetomotoric ultrasound

Intervention Type 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.

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Not able to give informed consent
* Synchronus colorectal cancer
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Region Skane

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Skane University Hospital, Malmö, section of Surgery

Malmo, Skåne County, Sweden

Site Status RECRUITING

Countries

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Sweden

Central Contacts

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Carl-Fredrik Rönnow, MD, PhD

Role: CONTACT

+4640-331635

Henrik Thorlacius, Professor

Role: CONTACT

+46 40-331000

Facility Contacts

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Carl-Fredrik Rönnow, MD, PhD

Role: primary

+46 40-331635

Henrik Thorlacius, Professor

Role: backup

+46 40-331000

Other Identifiers

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MAMORECT

Identifier Type: -

Identifier Source: org_study_id

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