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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03442543
• Other study ID #: MD/17.03.68
• Status: Recruiting
• Phase: Phase 1
• First received: February 16, 2018
• Last updated: February 21, 2018
• Start date: July 2, 2017
• Est. completion date: March 1, 2019

Study information

• Verified date: February 2018
• Source: Mansoura University
• Contact: Omar Hamdy, MSc
• Phone: +201003526752
• Email: omarhamdy87[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: March 1, 2019
• Est. primary completion date: July 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

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.

Locations

Country	Name	City	State
Egypt	Oncology center, Mansoura University	Mansourah

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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