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Magnetomotoric Ultrasound (MMUS) in Rectal Cancer (MAMORECT)

Primary Purpose

Rectal Cancer

Status
Recruiting
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Magnetomotoric ultrasound
Sponsored by
Region Skane
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Rectal Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • Not able to give informed consent
  • Synchronus colorectal cancer

Sites / Locations

  • Skane University Hospital, Malmö, section of SurgeryRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Magnetomotoric ultrasound

Arm Description

Magnetomotoric ultrasound in addition to MRI.

Outcomes

Primary Outcome Measures

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)
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.

Secondary Outcome Measures

Full Information

First Posted
September 6, 2021
Last Updated
February 12, 2023
Sponsor
Region Skane
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1. Study Identification

Unique Protocol Identification Number
NCT05052086
Brief Title
Magnetomotoric Ultrasound (MMUS) in Rectal Cancer
Acronym
MAMORECT
Official Title
Magnetomotoric Ultrasound (MMUS) in the Staging of Rectal Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2022 (Actual)
Primary Completion Date
December 20, 2023 (Anticipated)
Study Completion Date
January 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Region Skane

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectal Cancer

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Magnetomotoric ultrasound
Arm Type
Experimental
Arm Description
Magnetomotoric ultrasound in addition to MRI.
Intervention Type
Diagnostic Test
Intervention Name(s)
Magnetomotoric ultrasound
Intervention Description
Nanoparticles will be injected close to the tumor. Magnetomotoric ultrasound will be performed just before scheduled standard operation, when the patient is anesthetized.
Primary Outcome Measure Information:
Title
Accuracy of mesorectal lymph node diagnosis with MMUS, compared with final histopathology
Description
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)
Time Frame
Approximately 1 hour after MMUS
Title
Accuracy of mesorectal lymph node diagnosis with MMUS, compared with preoperative MRI
Description
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.
Time Frame
Approximately 1 hour after MMUS

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Rectal cancer Scheduled for total mesorectal surgery Informed consent Exclusion Criteria: Not able to give informed consent Synchronus colorectal cancer
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Carl-Fredrik Rönnow, MD, PhD
Phone
+4640-331635
Email
carl-fredrik.ronnow@med.lu.se
First Name & Middle Initial & Last Name or Official Title & Degree
Henrik Thorlacius, Professor
Phone
+46 40-331000
Email
henrik.thorlacius@med.lu.se
Facility Information:
Facility Name
Skane University Hospital, Malmö, section of Surgery
City
Malmö
State/Province
Skåne
ZIP/Postal Code
20501
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carl-Fredrik Rönnow, MD, PhD
Phone
+46 40-331635
Email
carl-fredrik.ronnow@med.lu.se
First Name & Middle Initial & Last Name & Degree
Henrik Thorlacius, Professor
Phone
+46 40-331000
Email
henrik.thorlacius@med.lu.se

12. IPD Sharing Statement

Plan to Share IPD
No

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Magnetomotoric Ultrasound (MMUS) in Rectal Cancer

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