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

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

Status

UNKNOWN

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03442543

Enrollment

Registered

2018-02-22

Start date

2017-07-02

Completion date

2019-03-01

Last updated

2018-02-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

sentinel lymph node biopsy

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.

Interventions

DEVICEpreoperative 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

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

Design outcomes

Primary

Measure	Time frame
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

Countries

Egypt

Contacts

Primary ContactOmar Hamdy, MSc

omarhamdy87@gmail.com+201003526752

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026