ClinicalTrials.gg
Status unknownNCT03442543Updated Feb 23, 2018

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

A Phase 1 interventional study of preoperative localization of SLN detected by CTLG by either methods in Breast Cancer, sponsored by Mansoura University. Status unknown at 1 site in Egypt. Per ClinicalTrials.gov, last updated 2018-02-23.

Sponsored by Mansoura University · Phase 1, Interventional, and Diagnostic

The sponsor has not verified this record recently (last verified Feb 2018), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 7 months after the study started (first participant enrolled Jul 2017, registered Feb 2018).
Phase
Phase 1
Study type
Interventional
Enrollment
50
Allocation
Randomized
Sex
All
01

Study 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.

02

Conditions studied

  • Breast Cancer

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Keywords

  • sentinel lymph node biopsy
03

In context

Breast Neoplasms

12,815 studies on the registry are indexed under Breast Neoplasms; 2,920 are open to participants now.

This study's planned enrollment of 50 is below the median of 72 across 9,494 interventional studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

Mansoura University is the lead sponsor of 1,114 studies on the registry; 185 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • node negative early breast cancer

Exclusion criteria

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
05

Study design

Phase
Phase 1
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
50 participants (estimated)

Study arms

  • Experimental
    charcoal

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

  • Experimental
    silver wire

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

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.

06

What researchers measure

Primary outcomes

  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

07

Study locations

1 of 1 sites recruiting
  • Oncology center, Mansoura University
    Al Mansurah, 35611, Egypt
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 23, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03442543
Responsible party
Omar Hamdy (Principal investigator, Assistant lecturer of surgical oncology, Mansoura University) — Principal investigator
First posted
Feb 22, 2018
Start date
Jul 2, 2017
Primary completion
Jul 1, 2018 (estimated)
Completion
Mar 1, 2019 (estimated)
Last update
Feb 23, 2018

Study contacts

Omar Hamdy, MSc
Contact
omarhamdy87@gmail.com
+201003526752
Omar Hamdy, MSc
principal investigator · Oncology center, Mansoura University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.

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