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

NCT ID: NCT05214781

Last Updated: 2022-02-14

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-09-14
• Study Completion Date: 2023-03-04

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.

Conditions

Breast Neoplasms

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Interventions

modified radical mastectomy

excision of the whole breast tissue including nipple and skin with axillary clearance

Intervention Type: PROCEDURE

Other Intervention Names

conservative breast surgey

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Mansoura University Hospital

OTHER

Sponsor Role: collaborator

Mansoura University

OTHER

Sponsor Role: lead

Responsible Party

Ayman Shemes

Assistant lecturer of general surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

faculty of medicine-Mansoura university - Egypt

Al Mansurah, , Egypt

Countries

Egypt

Other Identifiers

MD.21.09.521.R

Identifier Type: -

Identifier Source: org_study_id