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

December 15, 2023 updated by: Mennatallah Arous Mohamed

Evaluation of Different Imaging Modalities in Regional Nodes Staging in Breast Cancer Patient

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.

Study Overview

Status

Recruiting

Conditions

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.

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Egypt
      • Cairo, Egypt, 007
        • Recruiting
        • National Cancer Institute
        • Contact:
        • Contact:
          • amira h radwan
          • Phone Number: 0110000228

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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

Description

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

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
ultrasonography group
mammoragraphy group
patient with ultrasoundy only
CT group
pateint with postive node undergo further staging
MRI group
patient whit postive node with staging

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
evaluate the sensitivity of different Imaging modality pretherapeutic imaging modalities (sonography, mammography, CT and MRI) in pretherapeutic assessment of nodal-status in BC patients .
Time Frame: one year
one year

Secondary Outcome Measures

Outcome Measure
Time Frame
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.
Time Frame: one year
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mennatallah Arous Mohamed

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2024

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

January 12, 2025

Study Registration Dates

First Submitted

November 29, 2023

First Submitted That Met QC Criteria

December 15, 2023

First Posted (Actual)

December 29, 2023

Study Record Updates

Last Update Posted (Actual)

December 29, 2023

Last Update Submitted That Met QC Criteria

December 15, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Soh_med_23_11_02MD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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