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Magnetomotoric Ultrasound (MMUS) in Rectal Cancer (MAMORECT)

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ClinicalTrials.gov Identifier: NCT05052086
Recruitment Status : Recruiting
First Posted : September 22, 2021
Last Update Posted : September 22, 2021
Sponsor:
Information provided by (Responsible Party):
Region Skane

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 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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.
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Magnetomotoric Ultrasound (MMUS) in the Staging of Rectal Cancer
Estimated Study Start Date : October 1, 2021
Estimated Primary Completion Date : December 20, 2022
Estimated Study Completion Date : March 1, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

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.




Primary Outcome Measures :
  1. Accuracy of mesorectal lymph node diagnosis with MMUS, compared with final histopathology [ Time Frame: 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)

  2. Accuracy of mesorectal lymph node diagnosis with MMUS, compared with preoperative MRI [ Time Frame: 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Not able to give informed consent
  • Synchronus colorectal cancer

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05052086


Contacts
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Contact: Carl-Fredrik Rönnow, MD, PhD +4640-331635 carl-fredrik.ronnow@med.lu.se
Contact: Henrik Thorlacius, Professor +46 40-331000 henrik.thorlacius@med.lu.se

Locations
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Sweden
Skane University Hospital, Malmö, section of Surgery Recruiting
Malmö, Skåne, Sweden, 20501
Contact: Carl-Fredrik Rönnow, MD, PhD    +46 40-331635    carl-fredrik.ronnow@med.lu.se   
Contact: Henrik Thorlacius, Professor    +46 40-331000    henrik.thorlacius@med.lu.se   
Sponsors and Collaborators
Region Skane
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Responsible Party: Region Skane
ClinicalTrials.gov Identifier: NCT05052086    
Other Study ID Numbers: MAMORECT
First Posted: September 22, 2021    Key Record Dates
Last Update Posted: September 22, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases