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

M

Mansoura University

Status and phase

Unknown
Phase 1

Conditions

Breast Cancer

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT03442543
MD/17.03.68

Details and patient eligibility

About

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.

Enrollment

50 estimated patients

Sex

All

Volunteers

Accepts 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

Trial design

Primary purpose

Diagnostic

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

50 participants in 2 patient groups

charcoal
Experimental group
Treatment:
Device: preoperative localization of SLN detected by CTLG by either methods
silver wire
Experimental group
Treatment:
Device: preoperative localization of SLN detected by CTLG by either methods

Trial contacts and locations

1

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Central trial contact

Omar Hamdy, MSc

Data sourced from clinicaltrials.gov

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