Clinical trial NCT05214781: The Significance of Radiologically Detected Intramammary Lymph Nodes in Prediction of Axillary Lymph Nodes Status in Breast Cancer Patients
Official title: The Significance of Radiologically Detected Intramammary Lymph Nodes in Prediction of Axillary Lymph Nodes Status in Breast Cancer Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Breast Neoplasms
Keywords: breast surgery , breast cancer , magnetic resonance image
Lead sponsor: Mansoura University
Sponsor class: OTHER
Collaborators: name: Mansoura University Hospital
First posted: 2022-01-31
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

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.

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.

Primary outcomes:
measure: prediction of axillary lymph nodes status
timeFrame: 6 months
Secondary outcomes:
measure: pathological correlation
timeFrame: 7 months
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: faculty of medicine-Mansoura university - Egypt
Study officials:
References: