Clinical Application of Dual Sentinel Lymph Node Staining Method in Breast Cancer

NCT02168452 | Completed DMC

• 1 other identifier: NCC-1410201-1
• Study Type: observational
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

This study aimed to evaluate the feasibility of dual sentinel node staining method using mixture of indocyanine green(ICG) and radioisotope (RI) in breast cancer patients who receive neoadjuvant chemotherapy. Over the past few years, several studies have found using methylene blue, isosulfan blue, indocyanine green or radioisotope alone by detection method had several disadvantages. In this study we expects using mixture of indocyanine green (ICG) with radioisotope (RI) has potential to improve sentinel lymph node (SLN) mapping in breast cancer patients who receive neoadjuvant chemotherapy.

Conditions

Breast Cancer

Keywords

Neoadjuvant chemotherapy; Indocyanine green (ICG); Radioisotope (RI); Near infrared fluorescence camera

Outcome Measures

Primary Outcomes (1)

• Identification rate of sentinal lymph node biopsy

  It was defined as the ability to identify a sentinel lymph node successfully.

  during operation

Secondary Outcomes (1)

• duration of sentinel lymph node biopsy

  during operation

Other Outcomes (1)

• Physical assess

  follwing up a week to 3month

Interventions

sentinel lymph node biopsy(SLNB) PROCEDURE

* incision will be made over the skin site that had fluorescence lymphatic flow which visualized using fluorescence imaging camera and gamma probe. * double check after removal of the sentinel lymph node * sending frozen biopsy

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Breast cancer patients who receive neoadjuvant chemotherapy

You may qualify if:

• breast cancer patients who receive neoadjuvant chemotherapy
• cN1-cN2 or cT2 on tumor lymphnode metastasis classification(TNM)
• ECOG Performance status 0 or 1
• consented patients with more than 20 years, less than 70 years

You may not qualify if:

• history of breast cancer
• early stage breast cancer
• history of excisional or incisional biopsy or axillary dissection
• inflammatory breast carcinoma
• cN3 on tumor lymphnode metastasis classification(TNM)
• history of hormone therapy or targeted therapy
• stage 4 breast cancer
• pregnancy

Sponsors & Collaborators

• National Cancer Center, Korea: lead

Study Sites (1)

National Cancer Center

Goyang-si, Gyeonggi-do, 410-769, South Korea

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Sentinel Lymph Node Biopsy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Biopsy; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Lymph Node Excision; Investigative Techniques

Study Officials

• Seeyoun Lee

  National Cancer Center, Korea

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: June 18, 2014
• First Posted: June 20, 2014
• Study Start: June 1, 2014
• Primary Completion: September 1, 2014
• Study Completion: January 1, 2015
• Last Updated: February 5, 2016

Record last verified: 2016-02

Locations

KR (1)