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

NCT03442543 | Unknown Phase 1

• 1 other identifier: MD/17.03.68
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

sentinel lymph node biopsy

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

charcoal

EXPERIMENTAL

Device: preoperative localization of SLN detected by CTLG by either methods

silver wire

EXPERIMENTAL

Device: preoperative localization of SLN detected by CTLG by either methods

Interventions

preoperative localization of SLN detected by CTLG by either methods DEVICE

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.

charcoal; silver wire

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• node negative early breast cancer

You may not qualify if:

• 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

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Oncology center, Mansoura University

Al Mansurah, 35611, Egypt

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Omar Hamdy, MSc

  Oncology center, Mansoura University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Omar Hamdy, MSc

CONTACT

+201003526752; omarhamdy87@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator, Assistant lecturer of surgical oncology

Study Record Dates

• First Submitted: February 16, 2018
• First Posted: February 22, 2018
• Study Start: July 2, 2017
• Primary Completion: July 1, 2018
• Study Completion: March 1, 2019
• Last Updated: February 23, 2018

Record last verified: 2018-02

Locations

EG (1)