The Significance of Radiologically Detected Intramammary Lymph Nodes in Prediction of Axillary Lymph Nodes Status in Breast Cancer Patients

January 29, 2022 updated by: Ayman Shemes, Mansoura University

Breast cancer is a major cause of mortality among women if not treated in early stages. Early screening and diagnosis have a lot to do with the therapeutic effect of prognosis .

Nodal status in breast cancer is one of the determining factors for staging, treatment, and prognosis. Nodal status in breast cancer is one of the determining factors for staging, treatment, and prognosis. Nodal status in breast cancer is one of the determining factors for staging, treatment, and prognosis .

Intramammary lymph nodes (IMLN) are defined as a lymph nodes that should be surrounded by breast tissue in all sides, which differentiate them from those in the axillary region .

Normal IMLN are typically described in all imaging study (mammography, ultrasound and magnetic resonance imaging [MRI]) as a circumscribed mass, smaller than 10 mm, with oval shape and hilar fat, usually at a peripheral location, adjacent to a vein . The most common location (about 70%) is the upper outer quadrants, however, it may be located anywhere in the breast .

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Aim of the work

  • Primary outcome: prediction of axillary lymph nodes status by detection of Intramammary lymph nodes by radiological study.
  • Secondary outcome: pathological correlation of molecular subtypes of breast cancer with radiological results.

Patients and Methods This is a prospective study, which will be conducted at Mansoura University Hospital from September 2021 till September 2023. This study will include thirty patients with breast cancer, after informed written consent taken from each case before being included in the study.

• Inclusion criteria included: Female patients aged more than 18 years old presented with breast cancer with radiologically detected intramammary lymph nodes and agreed to participate in the study.

• Exclusion criteria included:

  1. Pregnancy.
  2. Psychological instability.
  3. Patients who refused to participate in our study.
  4. Patients whose age less than 18 years old. * The enrolled patients will be subjected to:

1-preoperative assessment: Detailed history and clinical breast examination.

Investigations:

Laboratory :

Complete blood picture (CBC) Liver function test Kidney function test International normalized ratio (INR)

Radiology:

Bilateral breast ultrasonography. Digital mammography for patients > 40 years old. Breast Dynamic Contrast Enhanced and diffusion weighted magnetic resonance imaging.

5- Operative techniques: Modified radical mastectomy and conservative breast surgery with axillary clearance 6- Post-Operative follow up:

  • Patient will stay in hospital for 1 to 2 days according to procedure and will be on antibiotic and analgesic according to hospital protocol.
  • follow up amount and the color of fluid which discharge from drain.
  • The wound is inspected after 48 h to be assessed.
  • Histopathological examination of the specimen
  • Immunohistochemistry will be done (estrogen receptor (ER) , progesterone receptor (PR) , HER-2neu and Ki-67 ) to determine the molecular subtypes of breast cancer
  • We will correlate pathological data to radiological results.
  • determine the post-operative type of systemic treatment according to pathological results.

Study Type

Observational

Enrollment (Anticipated)

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
      • Mansoura, Egypt, 35111
        • faculty of medicine-Mansoura university - Egypt

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

This is a prospective study, which will be conducted at Mansoura University Hospital from September 2021 till September 2023. This study will include thirty patients with breast cancer, after informed written consent taken from each case before being included in the study.

Description

Inclusion Criteria:

  • Female patients aged more than 18 years old presented with breast cancer with radiologically detected intramammary lymph nodes and agreed to participate in the study

Exclusion Criteria:

  • Pregnancy.
  • Psychological instability.
  • Patients who refused to participate in our study.
  • Patients whose age less than 18 years old.

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

  • Observational Models: Other
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
prediction of axillary lymph nodes status
Time Frame: 6 months
prediction of axillary lymph nodes status by detection of Intramammary lymph nodes by radiological study.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pathological correlation
Time Frame: 7 months
pathological correlation of molecular subtypes of breast cancer with radiological results.
7 months

Collaborators and Investigators

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

Sponsor

Mansoura University

Collaborators

Mansoura University Hospital

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)

September 14, 2021

Primary Completion (Anticipated)

August 4, 2022

Study Completion (Anticipated)

March 4, 2023

Study Registration Dates

First Submitted

January 4, 2022

First Submitted That Met QC Criteria

January 17, 2022

First Posted (Actual)

January 31, 2022

Study Record Updates

Last Update Posted (Actual)

February 14, 2022

Last Update Submitted That Met QC Criteria

January 29, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MD.21.09.521.R

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

This is a prospective study, which will be conducted at Mansoura University Hospital from September 2021 till September 2023. This study will include thirty patients with breast cancer, after informed written consent taken from each case before being included in the study.

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.

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