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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


Phase 2
20 Years
N/A
Not Enrolling
Female
Breast Neoplasms

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Trial Information

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


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


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Outcome Measure:

Time to sentinel lymph node biopsy

Outcome Description:

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).

Outcome Time Frame:

up to 6 months

Safety Issue:

Yes

Principal Investigator

So-Youn Jung

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Cancer Center, Korea

Authority:

Korea: National Cancer Center

Study ID:

NCC-1110212-2

NCT ID:

NCT01856452

Start Date:

September 2011

Completion Date:

October 2012

Related Keywords:

  • Breast Neoplasms
  • Sentinel lymph node
  • multimodal
  • breast cancer
  • Breast Neoplasms
  • Neoplasms

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