Comparison Study of Sentinel Lymph Node Biopsy by Multimodal Method in Breast Cancer

Sponsor

National Cancer Center, Korea (Other)

Overall Status

Completed

CT.gov ID

NCT01856452

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

6.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Sentinel lymph node biopsy (SLNB) has become a mainstay surgery method in breast cancer. It provides the surgeon the evidence of axillary lymph node metastasis, which determines the extent of surgery. Because effective SLNB can decrease the extent of axillary lymph node dissection, it is increasingly important. In general, radioactive colloid has been used for SLNB. In order to pursue more precise SLNB, the investigators developed a multimodal method enabling visual guidance with the mixture of indocyanine green, blue dye and radioisotope.

In this study, our hypotheses are as following:

Multimodal method enables to increase identification rate of SLNB
blue dye and indocyanine green provide the surgeon visual guidance to ensure better outcome
Multimodal method alleviates the shortcomings of indocyanine green and blue dye as an identification strategy

Condition or Disease	Intervention/Treatment	Phase
Breast Neoplasms	Device: the mixture including indocyanine green Device: radioisotope	Phase 2

Detailed Description

Indocyanine green Advantages: provides visualization of sentinel lymph node without incision

Blue dye Advantages: easy to employ; no toxicity Disadvantages: diffusion; absorption and disappearance of the marking within minutes

Radioisotope Advantages: can be used for lesions not accessible to Ultrasound; ideal for selective uptake to sentinel lymph node Disadvantages: not able to use palpation and visualization, confirms by gamma-probe only

Study Design

Study Type:

Interventional

Actual Enrollment :

86 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

Phase II Study of Comparison of Sentinel Lymph Node Biopsy Guided by The Multimodal Method of Indocyanine Green Fluorescence, Radioisotope and Blue Dye Versus the Radioisotope in Breast Cancer

Study Start Date :

Sep 1, 2011

Actual Primary Completion Date :

Oct 1, 2012

Actual Study Completion Date :

Oct 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: radioisotope sentinel lymph node operation using radioisotope in the breast cancer patients	Device: radioisotope Sentinel lymph node biopsy using gamma probe detector for radioisotope during operation
Experimental: the mixture including indocyanine green sentinel lymph node operation using the mixture of indocyanine green, blue dye and radioisotope in the breast cancer patients	Device: the mixture including indocyanine green Sentinel lymph node biopsy using near-infrared imaging system and gamma probe detector for the mixture of indocyanine green, blue dye, and radioisotope during operation

Arm

Intervention/Treatment

Active Comparator: radioisotope

sentinel lymph node operation using radioisotope in the breast cancer patients

Device: radioisotope

Sentinel lymph node biopsy using gamma probe detector for radioisotope during operation

Experimental: the mixture including indocyanine green

sentinel lymph node operation using the mixture of indocyanine green, blue dye and radioisotope in the breast cancer patients

Device: the mixture including indocyanine green

Sentinel lymph node biopsy using near-infrared imaging system and gamma probe detector for the mixture of indocyanine green, blue dye, and radioisotope during operation

Outcome Measures

Primary Outcome Measures

Time to sentinel lymph node biopsy [up to 6 months]
From the date of randomization, skin necrosis and dye staining are assessed up to 6 months after the operation (post op 3 mon and 6 mon follow-up).

Secondary Outcome Measures

Identification rate of sentinel lymph node biopsy [13 months]
The number of participants with sentinel lymph node detection is assessed up to 13 months.

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

clinically lymph node negative breast cancer patients
consented patients with more than 20 years

Exclusion Criteria:

history of breast cancer
locally advanced breast cancer and metastatic breast cancer
proven axillary lymph node metastasis
history of axillary excisional or incisional biopsy, or dissection
history of neoadjuvant chemotherapy
pregnancy
non-consented patients
younger than 20 years old

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	National Cancer Center	Goyang-si	Gyeonggi-do	Korea, Republic of	410-769

Sponsors and Collaborators

National Cancer Center, Korea

Investigators

Principal Investigator: So-Youn Jung, National Cancer Center, Korea

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

So-Youn Jung, Medical Doctor, National Cancer Center, Korea

ClinicalTrials.gov Identifier:

NCT01856452

Other Study ID Numbers:

NCC-1110212-2

First Posted:

May 17, 2013

Last Update Posted:

May 17, 2013

Last Verified:

May 1, 2013

Keywords provided by So-Youn Jung, Medical Doctor, National Cancer Center, Korea

Sentinel lymph node

multimodal

breast cancer

Additional relevant MeSH terms:

Breast Neoplasms

Study Results

No Results Posted as of May 17, 2013