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

Sponsor

Mansoura University (Other)

Overall Status

Unknown status

CT.gov ID

NCT03442543

Collaborator

(none)

Enrollment

Location

Arms

19.9

Anticipated Duration (Months)

2.5

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer	Device: preoperative localization of SLN detected by CTLG by either methods	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Diagnostic

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

Actual Study Start Date :

Jul 2, 2017

Anticipated Primary Completion Date :

Jul 1, 2018

Anticipated Study Completion Date :

Mar 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: charcoal	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.
Experimental: silver wire	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.

Arm

Intervention/Treatment

Experimental: charcoal

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.

Experimental: silver wire

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

Outcome Measures

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 [one year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Oncology center, Mansoura University	Mansourah		Egypt	35611

Sponsors and Collaborators

Mansoura University

Investigators

Principal Investigator: Omar Hamdy, MSc, Oncology center, Mansoura University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Omar Hamdy, Principal investigator, Assistant lecturer of surgical oncology, Mansoura University

ClinicalTrials.gov Identifier:

NCT03442543

Other Study ID Numbers:

MD/17.03.68

First Posted:

Feb 22, 2018

Last Update Posted:

Feb 23, 2018

Last Verified:

Feb 1, 2018

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Omar Hamdy, Principal investigator, Assistant lecturer of surgical oncology, Mansoura University

sentinel lymph node biopsy

Additional relevant MeSH terms:

Breast Neoplasms

Study Results

No Results Posted as of Feb 23, 2018