Preoperative Localization of Sentinel Lymph Node in Breast Cancer Patients By Novel Computed Tomography-Lymphography Guided Technique

Overview

A question is raised about the possibility of accurate localization of the SLN (sentinel lymph node) detected by CTLG (Computed Tomography Lymphography) which offers a detection rate of 100% in many studies In Oncology center, Mansoura University (OCMU), the surgical oncology unit had a previous experience in using charcoal for localization of non-palpable suspicious breast lesions and it showed promising results in comparison to traditional localization methods In addition, we had another study using silver wire for localization of breast masses before neoadjuvant therapy.

In the study, the investigators will study the usage of both methods as preoperative localization methods for the SLN detected by CT lymphography in breast cancer patients The investigators suppose that this method can offer two main advantages over the traditional SLN intraoperative methods which are; saving operative time needed for the intraoperative procedure as well as solving the problem of the need for complex logistic preparations especially for the usage of radioisotope method.

Full Title of Study: “A Novel Technique for Preoperative Localization of Sentinel Lymph Node in Breast Cancer Patients by Silver Wire Insertion or Liquid Charcoal Injection Guided by CT Lymphography”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Diagnostic
    • Masking: Single (Participant)
  • Study Primary Completion Date: July 1, 2018

Interventions

  • Device: preoperative localization of SLN detected by CTLG by either methods
    • 50 patients with node negative early breast cancer. The patients were randomized into two groups; SLN localized using CTLG guided injection of liquid charcoal suspended solution (first group) or by placing a 3 cm silver wire using spinal needle (second group). For every patient, SLN biopsy was performed using the traditional method with blue dye. Then dual search for the SLN localized by both the novel & traditional method was performed.

Arms, Groups and Cohorts

  • Experimental: charcoal
  • Experimental: silver wire

Clinical Trial Outcome Measures

Primary Measures

  • detection of the sentinel lymph node by the novel method & matching between the sentinel lymph node detected by the novel method and the control one
    • Time Frame: one year

Participating in This Clinical Trial

Inclusion Criteria

  • node negative early breast cancer

Exclusion Criteria

  • • Unfit patients for general anaesthesia
  • Previous axillary surgery
  • History of breast surgery or incisional biopsy compromising the breast lymphatic drainage.
  • Known hypersensitivity to the dye
  • Patients with clinically positive or suspicious axilla
  • Pregnant females

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Mansoura University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Omar Hamdy, Principal investigator, Assistant lecturer of surgical oncology – Mansoura University
  • Overall Official(s)
    • Omar Hamdy, MSc, Principal Investigator, Oncology center, Mansoura University
  • Overall Contact(s)
    • Omar Hamdy, MSc, +201003526752, omarhamdy87@gmail.com

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