NCT04274946

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable breast-cancer

Timeline
Completed

Started Jan 2019

Longer than P75 for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2019

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

February 16, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 18, 2020

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2021

Completed
4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2025

Completed
Last Updated

February 19, 2020

Status Verified

February 1, 2020

Enrollment Period

2 years

First QC Date

February 16, 2020

Last Update Submit

February 18, 2020

Conditions

Breast Cancer

Keywords

breastsentinel lymph nodepatent blueindocyanine green

Outcome Measures

Primary Outcomes (1)

  • Identification rate of sentinel lymph node

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

    During operation

Secondary Outcomes (3)

  • Average number of excised sentinel lymph nodes

    Histological report expected within an average of 2 weeks after sentinel lymph node biopsy

  • False-negative rate of axillary US

    Histological report expected within an average of 2 weeks after sentinel lymph node biopsy

  • Morbidity

    36 months

Study Arms (4)

RAI+PB+US

ACTIVE COMPARATOR

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

RAI+ICG+US

EXPERIMENTAL

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

RAI+PB+ICG+US

EXPERIMENTAL

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

PB+ICG+US

EXPERIMENTAL

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

Interventions

Sentinel lymph node biopsyPROCEDURE

Sentinel lymph node biopsy(SLNB) procedure with different mapping methods using combination of radioactive colloid, patent blue, indocyanine green associated with intraoperative ultrasound.

PB+ICG+USRAI+ICG+USRAI+PB+ICG+USRAI+PB+US

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bülent Ecevit University

Zonguldak, 67600, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Sentinel Lymph Node Biopsy

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

BiopsyCytodiagnosisCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisSpecimen HandlingDiagnostic Techniques, SurgicalSurgical Procedures, OperativeLymph Node ExcisionInvestigative Techniques

Study Officials

  • Güldeniz Karadeniz Cakmak, MD

    Bülent Ecevit University Department of Surgery

    STUDY CHAIR

  • Rabiye Uslu Erdemir, MD

    Bülent Ecevit University Department of Nucleer Medicine

    STUDY DIRECTOR

  • Hakan Bakkal, MD

    Bülent Ecevit University Department of Radiation Oncology

    PRINCIPAL INVESTIGATOR

  • Hüseyin Engin, MD

    Bülent Ecevit University Department of Clinical Oncology

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Guldeniz Karadeniz Cakmak, MD

CONTACT

05323371860gkkaradeniz@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Prospective, single-center, randomized study.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of General Surgery Departmet

Study Record Dates

First Submitted

February 16, 2020

First Posted

February 18, 2020

Study Start

January 1, 2019

Primary Completion

January 1, 2021

Study Completion

January 1, 2025

Last Updated

February 19, 2020

Record last verified: 2020-02

Locations

TU(1)