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

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ClinicalTrials.gov Identifier: NCT03442543
Recruitment Status : Recruiting
First Posted : February 22, 2018
Last Update Posted : February 23, 2018
Sponsor:
Information provided by (Responsible Party):
Omar Hamdy, 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.


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

Study Type : Interventional  (Clinical Trial)
Estimated 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 : July 2, 2017
Estimated Primary Completion Date : July 1, 2018
Estimated Study Completion Date : March 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

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.




Primary Outcome Measures :
  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 [ Time Frame: one year ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03442543


Contacts
Contact: Omar Hamdy, MSc +201003526752 omarhamdy87@gmail.com

Locations
Egypt
Oncology center, Mansoura University Recruiting
Mansourah, Egypt, 35611
Contact: Omar Hamdy, MSc    +201003526752    omarhamdy87@gmail.com   
Sponsors and Collaborators
Mansoura University
Investigators
Principal Investigator: Omar Hamdy, MSc Oncology center, Mansoura University

Responsible Party: Omar Hamdy, Principal investigator, Assistant lecturer of surgical oncology, Mansoura University
ClinicalTrials.gov Identifier: NCT03442543     History of Changes
Other Study ID Numbers: MD/17.03.68
First Posted: February 22, 2018    Key Record Dates
Last Update Posted: February 23, 2018
Last Verified: February 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Omar Hamdy, Mansoura University:
sentinel lymph node biopsy

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Charcoal
Antidotes
Protective Agents
Physiological Effects of Drugs