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Sentinel Lymph Node Biopsy With Hybrid Technique in Breast Cancer

Primary Purpose

Breast Cancer

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Sentinel lymph node biopsy
Sponsored by
Bulent Ecevit University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring breast, sentinel lymph node, patent blue, indocyanine green

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Bülent Ecevit UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Experimental

Experimental

Experimental

Arm Label

RAI+PB+US

RAI+ICG+US

RAI+PB+ICG+US

PB+ICG+US

Arm Description

Sentinel lymph node mapping with dual tracer (radioisotope and patent blue) and intraoperative ultrasound to identify SLN in the breast cancer patients

Sentinel lymph node mapping with dual tracer (radioisotope and ICG) and intraoperative ultrasound to identify SLN in the breast cancer patients

Sentinel lymph node mapping with triple tracer (radioisotope,ICG and patent blue) and intraoperative ultrasound to identify SLN in the breast cancer patients

Sentinel lymph node mapping with triple tracer (ICG and patent blue) and intraoperative ultrasound to identify SLN in the breast cancer patients

Outcomes

Primary Outcome Measures

Identification rate of sentinel lymph node
The ability to identify a sentinel lymph node successfully with different mapping techniques

Secondary Outcome Measures

Average number of excised sentinel lymph nodes
The effect of mapping technique on the number of excised nodes
False-negative rate of axillary US
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.
Morbidity
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%.

Full Information

First Posted
February 16, 2020
Last Updated
February 18, 2020
Sponsor
Bulent Ecevit University
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1. Study Identification

Unique Protocol Identification Number
NCT04274946
Brief Title
Sentinel Lymph Node Biopsy With Hybrid Technique in Breast Cancer
Official Title
The Comparative Analysis of Multimodal Markers to Identify Sentinel Lymph Node in Breast Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
January 1, 2021 (Anticipated)
Study Completion Date
January 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bulent Ecevit University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
breast, sentinel lymph node, patent blue, indocyanine green

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective, single-center, randomized study.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
RAI+PB+US
Arm Type
Active Comparator
Arm Description
Sentinel lymph node mapping with dual tracer (radioisotope and patent blue) and intraoperative ultrasound to identify SLN in the breast cancer patients
Arm Title
RAI+ICG+US
Arm Type
Experimental
Arm Description
Sentinel lymph node mapping with dual tracer (radioisotope and ICG) and intraoperative ultrasound to identify SLN in the breast cancer patients
Arm Title
RAI+PB+ICG+US
Arm Type
Experimental
Arm Description
Sentinel lymph node mapping with triple tracer (radioisotope,ICG and patent blue) and intraoperative ultrasound to identify SLN in the breast cancer patients
Arm Title
PB+ICG+US
Arm Type
Experimental
Arm Description
Sentinel lymph node mapping with triple tracer (ICG and patent blue) and intraoperative ultrasound to identify SLN in the breast cancer patients
Intervention Type
Procedure
Intervention Name(s)
Sentinel lymph node biopsy
Intervention Description
Sentinel lymph node biopsy(SLNB) procedure with different mapping methods using combination of radioactive colloid, patent blue, indocyanine green associated with intraoperative ultrasound.
Primary Outcome Measure Information:
Title
Identification rate of sentinel lymph node
Description
The ability to identify a sentinel lymph node successfully with different mapping techniques
Time Frame
During operation
Secondary Outcome Measure Information:
Title
Average number of excised sentinel lymph nodes
Description
The effect of mapping technique on the number of excised nodes
Time Frame
Histological report expected within an average of 2 weeks after sentinel lymph node biopsy
Title
False-negative rate of axillary US
Description
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.
Time Frame
Histological report expected within an average of 2 weeks after sentinel lymph node biopsy
Title
Morbidity
Description
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%.
Time Frame
36 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Guldeniz Karadeniz Cakmak, MD
Phone
05323371860
Email
gkkaradeniz@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Güldeniz Karadeniz Cakmak, MD
Organizational Affiliation
Bülent Ecevit University Department of Surgery
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Rabiye Uslu Erdemir, MD
Organizational Affiliation
Bülent Ecevit University Department of Nucleer Medicine
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Hakan Bakkal, MD
Organizational Affiliation
Bülent Ecevit University Department of Radiation Oncology
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hüseyin Engin, MD
Organizational Affiliation
Bülent Ecevit University Department of Clinical Oncology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bülent Ecevit University
City
Zonguldak
ZIP/Postal Code
67600
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
guldeniz karadeniz cakmak
Phone
05323371860
Email
gkkaradeniz@yahoo.com

12. IPD Sharing Statement

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Sentinel Lymph Node Biopsy With Hybrid Technique in Breast Cancer

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