Clinical Application of Dual Sentinel Lymph Node Staining Method in Breast Cancer
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|ClinicalTrials.gov Identifier: NCT02168452|
Recruitment Status : Completed
First Posted : June 20, 2014
Last Update Posted : February 5, 2016
This study aimed to evaluate the feasibility of dual sentinel node staining method using mixture of indocyanine green(ICG) and radioisotope (RI) in breast cancer patients who receive neoadjuvant chemotherapy.
Over the past few years, several studies have found using methylene blue, isosulfan blue, indocyanine green or radioisotope alone by detection method had several disadvantages.
In this study we expects using mixture of indocyanine green (ICG) with radioisotope (RI) has potential to improve sentinel lymph node (SLN) mapping in breast cancer patients who receive neoadjuvant chemotherapy.
|Condition or disease||Intervention/treatment|
|Breast Cancer||Procedure: sentinel lymph node biopsy(SLNB)|
- 5 patients who receive neoadjuvant chemotherapy with cN1-cN2 or cT2 on TNM staging
- sentinel lymph node biopsy(SLNB) by sentinel lymph node staining method using mixture of indocyanine green (ICG) with radioisotope (RI).
- indocyanine green (ICG) penetrates human tissue to depths of several millimeters to 2cm, and the fluorescence can be detected percutaneously in real time.
- using RI only has several disadvantages such as invisibility,interference. RI only detect sound or confirm numerical value through gamma probe.
- ICG can be visualized with a fluorescence imaging system
- confirm Identification rate of sentinal lymph node biopsy, and duration of sentinel lymph node biopsy
|Study Type :||Observational [Patient Registry]|
|Actual Enrollment :||5 participants|
|Target Follow-Up Duration:||3 Months|
|Official Title:||Clinical Application of Dual Sentinel Lymph Node Staining Method in Breast Cancer Patients Who Receive Neoadjuvant Chemotherapy; Observational Pilot Study|
|Study Start Date :||June 2014|
|Actual Primary Completion Date :||September 2014|
|Actual Study Completion Date :||January 2015|
Procedure: sentinel lymph node biopsy(SLNB)
- incision will be made over the skin site that had fluorescence lymphatic flow which visualized using fluorescence imaging camera and gamma probe.
- double check after removal of the sentinel lymph node
- sending frozen biopsy
- Identification rate of sentinal lymph node biopsy [ Time Frame: during operation ]It was defined as the ability to identify a sentinel lymph node successfully.
- duration of sentinel lymph node biopsy [ Time Frame: during operation ]It was defined as the time from the skin incision to complet removal of the first sentinel lymph node.
- Physical assess [ Time Frame: follwing up a week to 3month ]
- assess pigmented skin lesion
- assess for other complication
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02168452
|Korea, Republic of|
|National Cancer Center|
|Goyang-si, Gyeonggi-do, Korea, Republic of, 410-769|
|Principal Investigator:||Seeyoun Lee||National Cancer Center, Korea|