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

NCT01856452 | Completed Phase 2 DMC

• 1 other identifier: NCC-1110212-2
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

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:

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

Conditions

Breast Neoplasms

Keywords

Sentinel lymph node; multimodal; breast cancer

Outcome Measures

Primary Outcomes (1)

• Time to sentinel lymph node biopsy

  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).

  up to 6 months

Secondary Outcomes (1)

• Identification rate of sentinel lymph node biopsy

  13 months

Study Arms (2)

radioisotope

ACTIVE COMPARATOR

sentinel lymph node operation using radioisotope in the breast cancer patients

Device: radioisotope

the mixture including indocyanine green

EXPERIMENTAL

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

Interventions

the mixture including indocyanine green DEVICE

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

the mixture including indocyanine green

radioisotope DEVICE

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

radioisotope

Eligibility Criteria

• Age: 20 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

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

Condition Hierarchy (Ancestors)

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

Study Officials

• So-Youn Jung

  National Cancer Center, Korea

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: May 8, 2013
• First Posted: May 17, 2013
• Study Start: September 1, 2011
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2012
• Last Updated: May 17, 2013

Record last verified: 2013-05

Locations

KR (1)