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Evaluation of Different Imaging Modalities in Regional Lymph Nodes Staging in Patients With Breast Cancer

M

Mennatallah Arous Mohamed

Status

Enrolling

Conditions

Breast Carcinoma Metastatic in Lymph Node

Study type

Observational

Funder types

Other

Identifiers

NCT06185946
Soh_med_23_11_02MD

Details and patient eligibility

About

The regional lymph node status is considered to be an important prognostic factor regarding the long-term survival of breast cancer (BC) patients (Cetin IA, et al . 2020). The knowledge of whether lymph nodes are tumor-infiltrated or not is essential since nodal involvement has decisive therapeutic consequences such as axillary lymph node dissection (ALND), axillary radiotherapy, and neoadjuvant or adjuvant systemic chemotherapy (Diessner J et al . 2023). To provide individualized therapeutic options and optimized therapy.

Full description

The following data will be collected from electronic or paper medical data records as:

  1. Age 2 )Sex 3)Family history of breast cancer 4)Menopausal status 5 )Body mass index (BMI) 6) Histological type of BC as reported in pathology 7) The results of the lymph node status. 8)Registered data will be collected from the hospital databases and clinical sheers. 3 9) The gold standard reference in the evaluation of suspicious lymph nodes by nodal biopsy and postoperative pathology. Imaging technique and interpretation The imaging diagnostic for BC (MRI, CT, mammography, and ultrasound) patients are carried out by the Department of Diagnostic and Interventional Radiology of the Hospitals in the research and interpreted by radiologists at the time of BC diagnosis. The radiological reports for each patient and each imaging technique will be analyzed about the lymph node status. The nodal status will be reported as benign, indeterminate, and infiltrated as stated by the ACR lexicon. Mammography and US For mammography, we will use full-field digital mammography systems with the option of additional tomosynthesis for further characterization of the primary tumor at NCI with the commercially available The BC patients routinely receive an ultrasound exam including the evaluation of the breast and the axilla with the lymphatic drainage pathways as a part of the follow-up process active lymph nodes. p values lower than 0.05 will be considered significant.

Enrollment

100 estimated patients

Sex

Female

Ages

25 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  1. Patient consenting to participate in the study.
  2. Patients who can tolerate the imaging modalities and have proven to tolerate the contrast agents . 3) Breast cancer patients coming for an initial assessment with or without clinical regional lymph nodes positive status.
  1. Breast cancer patients planned to have(breast-conserving surgery or mastectomy)as well as lymph node surgeries(sentinel lymph node v biopsy and/or axillary lymph node dissection.

Exclusion criteria

1)Patients denying consent to participate in the study 2) Patients who are not fit for further imaging evaluation (patients who exceed the weight limit, patients who are sensitive to contrast material, etc). 3) Patients with bilateral MRM and AC

Trial design

100 participants in 4 patient groups

ultrasonography group
mammoragraphy group
Description:
patient with ultrasoundy only
CT group
Description:
pateint with postive node undergo further staging
MRI group
Description:
patient whit postive node with staging

Trial contacts and locations

1

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Central trial contact

Amira H Radwan, lecturer; Mennatallahh A Taha, assistant lecturer

Data sourced from clinicaltrials.gov

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