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

Phase 1

• Conditions: Breast Cancer
• Interventions: Device: preoperative localization of SLN detected by CTLG by either methods

• Registration Number: NCT03442543
• Lead Sponsor: Mansoura University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-07-02
• Status Verified: 2018-02
• Study First Submitted: 2018-02-16
• Study First Submitted QC: 2018-02-16
• Last Update Submitted: 2018-02-21
• Study First Posted: 2018-02-22
• Last Update Posted: 2018-02-23
• Primary Completion: 2018-07-01
• Study Completion: 2019-03-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
silver wire	preoperative localization of SLN detected by CTLG by either methods	-
charcoal	preoperative localization of SLN detected by CTLG by either methods	-

Primary Outcome Measures

Name	Time	Method
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	one year

Trial Locations

Locations (1)

Oncology center, Mansoura University; 🇪🇬 Mansourah, Egypt