Clinical Application of Near-infrared Fluorescence Guided Localization on Breast Surgery in Breast Cancer
1 other identifier
interventional
5
1 country
1
Brief Summary
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:
- 1.As inject only indocyanine green (ICG), it provide the surgeon visual guidance to ensure better outcome.
- 2.indocyanine green (ICG) permitted accurate preoperative and intraoperative detection of the SLNs as well as nonpalpable benign brest lesion in patients with breast cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2 breast-cancer
Started Mar 2015
Shorter than P25 for phase_2 breast-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2015
CompletedFirst Submitted
Initial submission to the registry
May 8, 2015
CompletedFirst Posted
Study publicly available on registry
June 16, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedJune 18, 2015
June 1, 2015
9 months
May 8, 2015
June 17, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
detection rate
after complete resection with intraoperative ultrasound confirmed the lesion
one day
Secondary Outcomes (1)
determine the pathological stability
one day
Other Outcomes (1)
detection rate and reoperation rate
participants will be followed for the duration of return to clinic, an expected average of 1 weeks
Study Arms (1)
indocyanine green
EXPERIMENTALAs inject only indocyanine green (ICG), it provide the surgeon visual guidance to ensure better outcome.
Interventions
As inject only indocyanine green (ICG), it provide the surgeon visual guidance to ensure better outcome.
Eligibility Criteria
You may qualify if:
- nonpalpable breast tumor ≤ 2cm in patients with breast cancer.
- patients who need breast biopsy as treatment for breast cancer.
- Eastern Cooperative Oncology Group Performance status 0 or 1
- consented patients with more than 20 years, less than 70 years
You may not qualify if:
- nonpalpable breast tumor ≥ 2cm in patients with breast cancer.
- pregnancy
- history of severe allergy to ICG(Indocyanine Green)
- iode hypersensitiveness
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Cancer Center
Goyang-si, Gyeonggi-do, 410-769, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
So-Youn Jung
National Cancer Center, Korea
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Medical Doctor
Study Record Dates
First Submitted
May 8, 2015
First Posted
June 16, 2015
Study Start
March 1, 2015
Primary Completion
December 1, 2015
Study Completion
December 1, 2015
Last Updated
June 18, 2015
Record last verified: 2015-06