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

• Conditions: Breast Neoplasms

• Registration Number: NCT05214781
• Lead Sponsor: Mansoura University

Brief Summary

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 .

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2021-09-14
• Status Verified: 2022-01
• Study First Submitted: 2022-01-04
• Study First Submitted QC: 2022-01-17
• Last Update Submitted: 2022-01-29
• Study First Posted: 2022-01-31
• Last Update Posted: 2022-02-14
• Primary Completion: 2022-08-04
• Study Completion: 2023-03-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 30

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

Read More

Exclusion Criteria

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

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
prediction of axillary lymph nodes status	6 months	prediction of axillary lymph nodes status by detection of Intramammary lymph nodes by radiological study.

Secondary Outcome Measures

Name	Time	Method
pathological correlation	7 months	pathological correlation of molecular subtypes of breast cancer with radiological results.

Trial Locations

Locations (1)

faculty of medicine-Mansoura university - Egypt; 🇪🇬 Mansoura, Egypt