Selective Lymph Node Dissection Using Fluorescent Dye in Node-positive Breast Cancer

Breast Neoplasms Clinical Trial

Official title:

Selective Lymph Node Dissection Using Fluorescent Dye in Node-positive Breast Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02781259
• Other study ID #: 2015-01-046-007
• Status: Recruiting
• Phase: Phase 4
• First received: May 8, 2016
• Last updated: September 18, 2016
• Start date: May 2016
• Est. completion date: April 2017

Study information

• Verified date: September 2016
• Source: Samsung Medical Center
• Contact: SeokWon Kim, MD. PhD.
• Phone: +82-2-3410-3479
• Email: seokwon1.kim[@]samsung.com
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

In this study, navigation of lymphatic passage after sentinel lymph node with indocyanine green was performed during axillary lymph node dissection in breast surgery . By comparing the concordance between the passage of indocyanine green and actual lymph node metastasis, selective lymph node dissection can be developed.

Description:

Low dose of indocyanine green emits near-infrared fluorescence, which can penetrate thin tissues like breast or skin. The operator can track the lymphatic pathway without skin incision in real time. By these characteristics, indocyanine green is currently used for sentinel lymph node biopsy in breast cancer surgery. Indocyanine green can also stain lymph nodes beyond the sentinel lymph nodes. This is why we can identify the lymphatic metastasis pathway of breast cancer.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: April 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 70 Years

Eligibility

Inclusion Criteria:

• Operable breast cancer patient

• Preoperatively axillary lymph node positive proven patients or sentinel lymph node positive patients whom requires axillary lymph node dissection

Exclusion Criteria:

• Breast cancer history

• Occult breast cancer

• Past history of axillary surgery

• Iodine hypersensitivity

• Pregnancy

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Breast Neoplasms

Intervention

Procedure:
• Axillary lymph node dissection
Lymph node dissection is performed in axillary lymph node level I and II. In case of palpable nodes in level II, additional lymph node dissection in level III is done.

Drug:
• Indocyanine green
10cc of 20µg/mL indocyanine green is injected at the nipple-areola complex before surgery

Device:
• Imaging devices
Near-infrared fluorescence is collected by imaging lenses and digital camera.

Locations

Country	Name	City	State
Korea, Republic of	Samsung medical center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of metastatic lymph nodes in fluorescent positive lymph nodes and fluorescent negative lymph nodes confirmed by pathologist	Concordance analysis is done by comparing lymph node metastasis between fluorescent positive lymph nodes and fluorescent negative lymph nodes.	within 2 weeks (plus or minus 3 days) after surgery	No
Secondary	Clinicopathological factors associated with lymph node metastasis in fluorescent negative lymph nodes	Risk factor analysis of fluorescent negative lymph node with positive lymph node metastasis	within 2 weeks (plus or minus 3 days) after surgery	No