Clinical trial NCT06185946: Evaluation of Different Imaging Modalities in Regional Lymph Nodes Staging in Patients With Breast Cancer
Official title: Evaluation of Different Imaging Modalities in Regional Nodes Staging in Breast Cancer Patient
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Breast Carcinoma Metastatic in Lymph Node
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2023-12-29
Enrollment: 100
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The plan is to study a population of 100 patients of BC presenting to Sohag university And NCI in breast cancer clinic surgery the Late 2023 and 2024

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

4) 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

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Primary outcomes:
measure: evaluate the sensitivity of different Imaging modality pretherapeutic imaging modalities (sonography, mammography, CT and MRI) in pretherapeutic assessment of nodal-status in BC patients .
timeFrame: one year
Secondary outcomes:
measure: to find out if there is further benefit of using cross-sectional imaging (MRI, CT) for pretherapeutic axillary staging compared to Us and mammogram conventional imaging such as mammography and sonogram.
timeFrame: one year
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: National Cancer Institute
Study officials:
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