The Role of Magnetic Resonance Imaging in Assessment of Axillary Lymph Nodes Metastasis in Breast Cancer Patients.

July 30, 2021 updated by: Sandy Harby, Assiut University

The Role of Unenhanced Magnetic Resonance Imaging in Quantitative Assessment of Metastatic Involvement of Axillary Lymph Nodes in Patients With Breast Cancer: Observational Descriptive Study.

Breast cancer is the most common cancer among women worldwide.The main cause of cancer related death is the invasion and metastasis. The usual site of spread outside the breast is to lymph nodes in the axilla.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The presence of axillary metastasis is important for prognosis and determining of treatment plan, so identification of axillary metastasis in early stage newly diagnosed breast cancer is important for staging of disease and treatment. However, approximately 40% of women who presents with early stage breast cancer also have axillary metastasis.

The status of lymph nodes in patients with breast cancer used to be evaluated with axillary lymph node dissection. During the last 15 years, sentinel lymph node biopsy has replaced for grading of patients with clinically lymph node negative breast cancer. Despite being a less invasive method when compared to axillary lymph node dissection, sentinel lymph node biopsy also leads to complications such as lymphedema, seroma, localized swelling, pain, paresthesia, decrease in arm strength, infectious neuropathy and shoulder stiffness in 20% of patients.

The imaging modalities for assessing the axillary lymph nodes are rapidly evolving. Ultrasound is applied widely for its convincing and dynamic observation. However, the sensitivity and specificity of ultrasound for lymph node metastasis were unreliable and controversial.

Owing to radiation and relative lower diagnostic accuracy, computed tomography is limited in clinic.

Positron emission tomography and positron emission tomography/computed tomography can reflect metabolism of glycolytic activity. Undoubtedly, they have shown the higher diagnostic significance in assessing distant metastasis and regional metastatic axillary lymph nodes, but their high radiation and expensive fee keep the common people away. Ultrasmall super paramagnetic iron oxide is the same.

Magnetic resonance imaging is developing with an unimaginable speed. Over the past years, it has been used to evaluate axillary lymph nodes. Its sensitivity and specificity for metastatic axillary lymph nodes were higher than ultrasound and computed tomography.

Diffusion weighted imaging is an advanced magnetic resonance imaging application which derives its image contrast from the differences in water mobility in the extracellular spaces, reflecting cellular density, organization, microstructure and microcirculation.

Several studies have shown that diffusion weighted imaging can serve as a powerful tool for differentiating benign from malignant breast lesions. In addition to this use, diffusion weighted imaging may also be used in the assessment of axillary lymph nodes, since they show similar tissue characteristics to the primary tumor.

Evaluation of lymph nodes is a promising novel application of diffusion weighted imaging , which can easily be applied as an adjunct to conventional breast magnetic resonance imaging . There are a few preliminary studies that have shown that diffusion weighted imaging can be used to detect lymph nodes affected by malignant cells. Koh reported that after the involvement of nodes with malignancy, they undergo changes and the increase in cellularity leads to diffusion restriction and low apparent diffusion coefficient values.

Study Type

Observational

Enrollment (Actual)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Assiut, Egypt
        • South Egypt Cancer Institute
      • Assiut, Egypt
        • Faculty of medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Female patients who are coming to South Egypt Cancer Institute- Assiut University and proved positive for primary breast cancer by histopathology with axillary lymph nodes detected clinically or with superficial ultrasound on both axillae.

Description

Inclusion Criteria:

- 1) Patients who proved positive for primary breast cancer by histopathology with axillary lymph nodes detected clinically or with superficial ultrasound on both axillae.

2) The included lymph nodes with minimal axial diameter (4mm).

Exclusion Criteria:

  • 1)Patients who have a heart pacemaker as they are absolutely contraindicated for magnetic resonance imaging.

    2) Patients with severe claustrophobia. 3) Patients undergoing any type of neoadjuvant chemo-, immune- or endocrine therapy.

    4) Patients with history of axillary surgery or treatment. 5) Patients with recurrent axillary disease.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Breast cancer patients
Patients will undergo unenhanced magnetic resonance imaging on both axillae.
Other: Unenhanced magnetic resonance imaging.

The axillary lymph nodes will be evaluated on axial Time 1-weighted images obtained without fat saturation. We will measure the largest dimension and cortical thickness of each lymph node and ratio of the two measurements will be calculated.

The lymph nodes seen in Time 1-weighted images will be subsequently identified on the diffusion-weighted images to calculate the apparent diffusion coefficient value of each lymph node.

Axillary lymph nodes scanned by magnetic resonance imaging will be compared by results of histopathological examination.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Accuracy of unenhanced magnetic resonance imaging in assessment of axillary lymph node metastasis in breast cancer patients.
Time Frame: one month
number of malignant axillary lymph nodes are accurately diagnosed by unenhanced magnetic resonance imaging in compared with histopathological result.
one month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Principal Investigator: Sandy HN Ghaly, MBBCh, Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2017

Primary Completion (Actual)

June 1, 2021

Study Completion (Actual)

July 1, 2021

Study Registration Dates

First Submitted

May 20, 2017

First Submitted That Met QC Criteria

May 20, 2017

First Posted (Actual)

May 23, 2017

Study Record Updates

Last Update Posted (Actual)

August 3, 2021

Last Update Submitted That Met QC Criteria

July 30, 2021

Last Verified

December 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MRIALBC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Breast Cancer Female

Clinical Trials on Unenhanced magnetic resonance imaging.

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mauritius

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe