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
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 86
- Locations
- 2
- Primary Endpoint
- Time to sentinel lymph node biopsy
Study Overview
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
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
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 20 Years to — (Adult, Older Adult)
- Sex
- 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
Outcomes
Primary Outcomes
Time to sentinel lymph node biopsy
Time Frame: 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 Outcomes
- Identification rate of sentinel lymph node biopsy(13 months)
Investigators
So-Youn Jung
Medical Doctor
National Cancer Center, Korea