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

NCT05214781 | Unknown

• 1 other identifier: MD.21.09.521.R
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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 .

Conditions

Breast Neoplasms

Keywords

breast surgery , breast cancer , magnetic resonance image

Outcome Measures

Primary Outcomes (1)

• prediction of axillary lymph nodes status

  prediction of axillary lymph nodes status by detection of Intramammary lymph nodes by radiological study.

  6 months

Secondary Outcomes (1)

• pathological correlation

  7 months

Interventions

modified radical mastectomy PROCEDURE

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

Also known as: conservative breast surgey

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Mansoura University: lead
• Mansoura University Hospital: collaborator

Study Sites (1)

faculty of medicine-Mansoura university - Egypt

Al Mansurah, 35111, Egypt

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Mastectomy, Modified Radical

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Mastectomy, Radical; Mastectomy; Surgical Procedures, Operative

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer of general surgery

Study Record Dates

• First Submitted: January 4, 2022
• First Posted: January 31, 2022
• Study Start: September 14, 2021
• Primary Completion: August 4, 2022
• Study Completion: March 4, 2023
• Last Updated: February 14, 2022

Record last verified: 2022-01

Locations

EG (1)