Back to results

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

Primary Purpose

Breast Cancer

Status

Unknown status

Phase

Phase 1

Locations

Egypt

Study Type

Interventional

Intervention

preoperative localization of SLN detected by CTLG by either methods

About this trial

This is an interventional diagnostic trial for Breast Cancer focused on measuring sentinel lymph node biopsy

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Oncology center, Mansoura UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

charcoal

silver wire

Arm Description

Outcomes

Primary Outcome 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

Secondary Outcome Measures

Full Information

NCT ID

NCT03442543

First Posted

February 16, 2018

Last Updated

February 21, 2018

Sponsor

Mansoura University

1. Study Identification

Unique Protocol Identification Number

NCT03442543

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2018

Overall Recruitment Status

Unknown status

Study Start Date

July 2, 2017 (Actual)

Primary Completion Date

July 1, 2018 (Anticipated)

Study Completion Date

March 1, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Mansoura University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Cancer

Keywords

sentinel lymph node biopsy

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

charcoal

Arm Type

Experimental

Arm Title

silver wire

Arm Type

Experimental

Intervention Type

Device

Intervention Name(s)

preoperative localization of SLN detected by CTLG by either methods

Intervention Description

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.

Primary Outcome Measure Information:

Title

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

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Omar Hamdy, MSc

Phone

+201003526752

omarhamdy87@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Omar Hamdy, MSc

Organizational Affiliation

Oncology center, Mansoura University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Oncology center, Mansoura University

City

Mansourah

ZIP/Postal Code

35611

Country

Egypt

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Omar Hamdy, MSc

Phone

+201003526752

omarhamdy87@gmail.com

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs