Preoperative Localization of Sentinel Lymph Node in Breast Cancer Patients By Novel Computed Tomography-Lymphography Guided Technique
NCT ID: NCT03442543
Last Updated: 2018-02-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1
50 participants
INTERVENTIONAL
2017-07-02
2019-03-01
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
SINGLE
Study Groups
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charcoal
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.
silver wire
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
ALL
Yes
Sponsors
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Mansoura University
OTHER
Responsible Party
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Omar Hamdy
Principal investigator, Assistant lecturer of surgical oncology
Principal Investigators
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Omar Hamdy, MSc
Role: PRINCIPAL_INVESTIGATOR
Oncology center, Mansoura University
Locations
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Oncology center, Mansoura University
Al Mansurah, , Egypt
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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MD/17.03.68
Identifier Type: -
Identifier Source: org_study_id
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