Clinical Application of Near-infrared Fluorescence Guided Localization on Breast Surgery in Benign Breast Neoplasm.
|ClinicalTrials.gov Identifier: NCT02172989|
Recruitment Status : Completed
First Posted : June 24, 2014
Last Update Posted : June 19, 2015
Near-infrared (NIR) fluorescence imaging using indocyanine green (ICG) has been used for breast cancer surgery such as sentinel lymph node (SLN) mapping and breast cancer localization.
In this study, our hypothesis are as following:
- As inject only indocyanine green (ICG), it provide the surgeon visual guidance to ensure better outcome.
- indocyanine green (ICG) permitted accurate preoperative and intraoperative detection of the SLNs as well as nonpalpable benign brest lesion in patients with breast cancer.
|Condition or disease||Phase|
|Benign Breast Neoplasm||Phase 1 Phase 2|
Indocyanine green, ICG (ICG-fluorescence)
- ICG is the most commonly used fluorophore which approve by FDA.
- NIR-F imaging with ICG could be used in various surgeries. For example, SLN mapping in breast cancer and localization of liver metastasis, especially superficial lesion
- Contains sodium iodide, patients who have history of allergy to iodides should be used as caution.
Nonpalpable benign brest lesion localization
- New method for the localization and resection of non-palpable breast lesions.
- The breast lesion was correctly localized, and the area of ICG corresponded well to the site of the lesions.
|Study Type :||Observational [Patient Registry]|
|Actual Enrollment :||20 participants|
|Target Follow-Up Duration:||1 Week|
|Official Title:||Clinical Application of Near-infrared Fluorescence Guided Localization on Breast Surgery in Benign Breast Neoplasm ; Observational Pilot Study for 20 Patients.|
|Study Start Date :||June 2014|
|Primary Completion Date :||April 2015|
|Study Completion Date :||May 2015|
- non-palpable lesion localization rate [ Time Frame: up to 6month ]non-palpable lesion localization rate = number of patients complete excision of lesion / 20 enrolled patients
- lesion of resection size, completeness of resection [ Time Frame: up to 6month ]actual lesion of width*height*length / resection lesion of width*height*length
- physical assess [ Time Frame: following up a week to 6 month ]number of patients with pigmented skin lesion, number of patients with complication, number of patients with breast lymphedema, number of patients with residual breast lesion using breast ultrsound
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02172989
|Korea, Republic of|
|National Cancer Center|
|Goyang-si, Gyeonggi-do, Korea, Republic of, 410-769|
|Principal Investigator:||So-Youn Jung||National Cancer Center, Korea|