Sentinel Lymph Node Biopsy With Hybrid Technique in Breast Cancer

February 18, 2020 updated by: Guldeniz Karadeniz Cakmak, Bulent Ecevit University

The Comparative Analysis of Multimodal Markers to Identify Sentinel Lymph Node in Breast Cancer

Sentinel lymph node (SLN) biopsy is the gold standard method to stage axilla in breast cancer. The aim of the study is to compare the efficiency of various methods to identify SLN is breast cancer patients.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Various markers has been used for SLN biopsy including isosulfan blue (patent blue), indocyanine green (ICG), radioisotope colloid (RAIC) and ultrasound (US) with several advantages and disadvantages. In this study investigators designed an algorithm using the combination of mapping with patent blue, ICG, RAIC and US to compare the accurate identification of SLN in breast cancer patients. The protocol is based on the hypothesis that identification rate of SLN is increased with multiple agents. Patent blue and ICG provides visual guidance. The combination of dyes with sonographic and RAIC method have the potential to prevent obstacles and ensure better outcomes as an identification strategy.

Patent blue provides visual identification of the SLN. ICG fluorescence can be detected percutaneously and by means of fluorescence imaging system in real time. RAI has several advantages, but disadvantages as well, like cost and invisibility. RAI can only be detected and confirmed by means of sound and numerical value through gamma probe. All breast cancer patients underwent axillary ultrasound before SLNB with different mapping combinations. The determination of abnormal axillary lymph node was followed by ultrasound-guided FNA cytology of these nodes. The sonographic abnormality criteria of the nodes were defined as; completely hypoechoic node, asymmetric focal hypoechoic node, cortical lobulation more than 3, cortical thickness >2mm, totally spheric appearance, absence of fatty hilum and compromise of normal vascularity (hypervascularization from various poles). Patients with negative results of FNA would undergo SLNB. Lymphatic mapping was performed with abovementioned dyes and radioactive colloid. Before the incising for SLNB real time intraoperative US was performed and suspicious axillary lymph nodes were seen by ultrasound guidance. In the SLNB operation, radioactive or dyed nodes and sonographically suspicious nodes were removed and labeled separately for pathological examination.

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Turkey
      • Zonguldak, Turkey, 67600
        • Recruiting
        • Bulent Ecevit University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 88 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Histologically confirmed primary breast cancer by core needle, incisional or excisional biopsy
  • cN0 patients
  • In patients with abnormal axillary lymph nodes sonographically US-guided FNA cytology of these nodes were performed and FNA cytology negative patients planed to undergo SLNB with different mapping techniques.

Exclusion Criteria:

  • Patients with neoadjuvant therapy
  • Patients with pathological diagnosed ductal carcinoma in situ by excisional biopsy
  • Patients with pathologically proven axillary disease
  • Patients with T4d tumor

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: RAI+PB+US
Sentinel lymph node mapping with dual tracer (radioisotope and patent blue) and intraoperative ultrasound to identify SLN in the breast cancer patients
Procedure: Sentinel lymph node biopsy
Sentinel lymph node biopsy(SLNB) procedure with different mapping methods using combination of radioactive colloid, patent blue, indocyanine green associated with intraoperative ultrasound.
Experimental: RAI+ICG+US
Sentinel lymph node mapping with dual tracer (radioisotope and ICG) and intraoperative ultrasound to identify SLN in the breast cancer patients
Procedure: Sentinel lymph node biopsy
Sentinel lymph node biopsy(SLNB) procedure with different mapping methods using combination of radioactive colloid, patent blue, indocyanine green associated with intraoperative ultrasound.
Experimental: RAI+PB+ICG+US
Sentinel lymph node mapping with triple tracer (radioisotope,ICG and patent blue) and intraoperative ultrasound to identify SLN in the breast cancer patients
Procedure: Sentinel lymph node biopsy
Sentinel lymph node biopsy(SLNB) procedure with different mapping methods using combination of radioactive colloid, patent blue, indocyanine green associated with intraoperative ultrasound.
Experimental: PB+ICG+US
Sentinel lymph node mapping with triple tracer (ICG and patent blue) and intraoperative ultrasound to identify SLN in the breast cancer patients
Procedure: Sentinel lymph node biopsy
Sentinel lymph node biopsy(SLNB) procedure with different mapping methods using combination of radioactive colloid, patent blue, indocyanine green associated with intraoperative ultrasound.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Identification rate of sentinel lymph node
Time Frame: During operation
The ability to identify a sentinel lymph node successfully with different mapping techniques
During operation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Average number of excised sentinel lymph nodes
Time Frame: Histological report expected within an average of 2 weeks after sentinel lymph node biopsy
The effect of mapping technique on the number of excised nodes
Histological report expected within an average of 2 weeks after sentinel lymph node biopsy
False-negative rate of axillary US
Time Frame: Histological report expected within an average of 2 weeks after sentinel lymph node biopsy
False negative rate for SLN surgery in women with normal or axillary US and at least 2 SLNs were excised, defined as the number of patients with no positive lymph nodes by SLN and with at least one positive lymph node by axillary lymph node dissection divided by the total number of patients with at least one positive lymph node by SLN or ALND multiplied by 100, or vise versa. For abnormal axillary US, false negative rate is calculated similarly.
Histological report expected within an average of 2 weeks after sentinel lymph node biopsy
Morbidity
Time Frame: 36 months
Lymphedema, shoulder movement pain, or functional deformity after SLNB with different mapping techniques will be assessed by clinicians during follow-up with 3 months periods. The result will be the percentage of patients which suffer from some complications after SLNB or AD. Common morbidity rate after AD is 20%, after SLNB 1-2%.
36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bulent Ecevit University

Investigators

  • Study Chair: Güldeniz Karadeniz Cakmak, MD, Bülent Ecevit University Department of Surgery
  • Study Director: Rabiye Uslu Erdemir, MD, Bülent Ecevit University Department of Nucleer Medicine
  • Principal Investigator: Hakan Bakkal, MD, Bülent Ecevit University Department of Radiation Oncology
  • Principal Investigator: Hüseyin Engin, MD, Bülent Ecevit University Department of Clinical Oncology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2019

Primary Completion (Anticipated)

January 1, 2021

Study Completion (Anticipated)

January 1, 2025

Study Registration Dates

First Submitted

February 16, 2020

First Submitted That Met QC Criteria

February 16, 2020

First Posted (Actual)

February 18, 2020

Study Record Updates

Last Update Posted (Actual)

February 19, 2020

Last Update Submitted That Met QC Criteria

February 18, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019-09-09

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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