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

NCT ID: NCT02479997

Last Updated: 2023-02-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 130 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-03-31
• Study Completion Date: 2018-03-27

Brief Summary

This study aimed to compare detection rate between dual sentinel node staining method using mixture of indocyanine green (ICG) with radioisotope(RI), and RI only.

To identify the first lymph node(s) along the lymphatic drainage pathway from the primary tumor in the breast cancer using RI only has several disadvantages such as invisibility, interference. As ICG can be visualized with a fluorescence imaging system, we expects dual sentinel lymph node staining method had better outcomes.

Detailed Description

Using mixture of indocyanine green (ICG) with radioisotope (RI) can guide surgeons to identify the first lymph node(s) along the lymphatic drainage pathway from the primary tumor in the breast to the axillary lymph node basin.

Last pilot study, sentinel lymph node was successfully identified by using dual method of ICG and RI in 5 patients. In this study, when radiolabeled colloid is used, a gamma probe identifies radioactivity in the lymph nodes in the axilla. If ICG, RI both used, Near infrared fluorescence camera visualized during surgery.

As investigators measure node detection time from axillary approach moment, investigators are going to compare detection rate. (ICG+RI or RI only). And determine the accuracy.

Sentinel lymph node mapping with both ICG and radiolabeled colloid mapping agents was recommended to maximize the likelihood of SLN identification and to minimize the possibility of missing SLNs, which could result in a false-negative event.The protocol required that 130 patients who receive neoadjuvant chemotherapy.

In this study investigators 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.

Sentinel lymph node mapping with both ICG and radiolabeled colloid mapping agents was recommended to maximize the likelihood of SLN identification and to minimize the possibility of missing SLNs, which could result in a false-negative event.

Conditions

Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Radioisotope (RI)

Using RI only as SLNB mapping in breast cancer patients who receive neoadjuvant chemotherapy.

Interventions - patient assigend RI groups are injected only RI

• fill the Primay Case Report Form during surgery

• PCRF including SLN detection time, duration of SLN approch time to 1st sentinel node dection time, incision length , depth, RI +/- .

Group Type: ACTIVE_COMPARATOR

Indocyanine green

Intervention Type: DRUG

ICG is cyanine dye used in medical diagnostics. It is used for determining cardiac output, hepatic function, and liver blood flow, and for ophthalmic angiography.

In this study, Investigator uses ICG as a fluorescent dye which is used in medicine as an indicator substance . And it will allow detection of SLN more convenientlty.

Radioisotope

Intervention Type: DRUG

Nuclear medicine uses radiation to provide diagnostic information about the functioning of a person's specific organs, or to treat them. Diagnostic procedures using radioisotopes are now routine.

Indocyanine green (ICG) +RI

Dual sentinel node staining method using mixture of indocyanine green (ICG) and radioisotope (RI) in breast cancer patients who receive neoadjuvant chemotherapy.

Interventions - patient assigend RI groups are injected RI +ICG

• prepare fluorescence camera when the surgery begin
• surgeon uses the camera to decect fluorescence flow on SLN
• fill the Primay Case Report Form during surgery

• PCRF including SLN detection time, duration of SLN approch time to 1st sentinel node dection time, incision length , depth, RI +/- , ICG+/-

Group Type: ACTIVE_COMPARATOR

Indocyanine green

Intervention Type: DRUG

ICG is cyanine dye used in medical diagnostics. It is used for determining cardiac output, hepatic function, and liver blood flow, and for ophthalmic angiography.

In this study, Investigator uses ICG as a fluorescent dye which is used in medicine as an indicator substance . And it will allow detection of SLN more convenientlty.

Radioisotope

Intervention Type: DRUG

Nuclear medicine uses radiation to provide diagnostic information about the functioning of a person's specific organs, or to treat them. Diagnostic procedures using radioisotopes are now routine.

Interventions

Indocyanine green

ICG is cyanine dye used in medical diagnostics. It is used for determining cardiac output, hepatic function, and liver blood flow, and for ophthalmic angiography.

In this study, Investigator uses ICG as a fluorescent dye which is used in medicine as an indicator substance . And it will allow detection of SLN more convenientlty.

Intervention Type: DRUG

Radioisotope

Nuclear medicine uses radiation to provide diagnostic information about the functioning of a person's specific organs, or to treat them. Diagnostic procedures using radioisotopes are now routine.

Intervention Type: DRUG

Other Intervention Names

ICG; RI

Eligibility Criteria

Inclusion Criteria

• breast cancer patients who receive neoadjuvant therapy (chemotherapy,hormonal therapy, targeted therapy)
• cN1-cN2 or cN3( but must be complete response status)on tumor lymphnode metastasis classification( TNM) after neoadjuvant therapy.
• ECOG Performance status 0 or 1
• consented patients with more than 20 years, less than 70 years

Exclusion Criteria

• 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)
• stage 4 breast cancer
• pregnancy

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Center, Korea

OTHER_GOV

Sponsor Role: lead

Responsible Party

Seeyoun Lee

Medical Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Seeyoun Lee

Role: PRINCIPAL_INVESTIGATOR

National Cancer Center

Locations

National Cancer Center

Goyang-si, Gyeonggi-do, South Korea

Countries

South Korea

Other Identifiers

NCC-1410201-2

Identifier Type: -

Identifier Source: org_study_id