Clinical trial NCT04274946: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Cancer
Keywords: breast
sentinel lymph node
patent blue
indocyanine green
Lead sponsor: Bulent Ecevit University
Sponsor class: OTHER
First posted: 2020-02-18
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, single-center, randomized study.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Identification rate of sentinel lymph node
timeFrame: During operation
Secondary outcomes:
measure: Average number of excised sentinel lymph nodes
timeFrame: Histological report expected within an average of 2 weeks after sentinel lymph node biopsy
measure: False-negative rate of axillary US
timeFrame: Histological report expected within an average of 2 weeks after sentinel lymph node biopsy
measure: Morbidity
timeFrame: 36 months
Other outcomes:
Locations:
city: Zonguldak
country: Turkey
facility: Bülent Ecevit University
Study officials:
affiliation: Bülent Ecevit University Department of Surgery
name: Güldeniz Karadeniz Cakmak, MD
role: STUDY_CHAIR
affiliation: Bülent Ecevit University Department of Nucleer Medicine
name: Rabiye Uslu Erdemir, MD
role: STUDY_DIRECTOR
affiliation: Bülent Ecevit University Department of Radiation Oncology
name: Hakan Bakkal, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Bülent Ecevit University Department of Clinical Oncology
name: Hüseyin Engin, MD
role: PRINCIPAL_INVESTIGATOR
References: