A Prospective Clinical Study for Evaluation of Safe Resection Margin in Breast Conserving Surgery in Breast Cancer
1 other identifier
interventional
149
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 P75+ for phase_2 breast-cancer
Started Mar 2016
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, 2016
CompletedFirst Submitted
Initial submission to the registry
June 1, 2016
CompletedFirst Posted
Study publicly available on registry
June 29, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedJune 29, 2016
June 1, 2016
6 months
June 1, 2016
June 26, 2016
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 (3)
Side effects and availability Side effects and availability Side effects and availability side effects and availability
following up a week to 3 month
side effects and availability
following up a week to 3 month
side effects ans availability
following up a week to 3 month
Study Arms (1)
indocyanine green
EXPERIMENTALAs inject only indocyanine green (ICG), it provide the surgeon visual guidance to ensure better outcome. Intervention: Drug: indocyanine green
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 \< 5cm in patients with breast cancer.
- consented patients with more than 18 years
- Eastern Cooperative Oncology Group Performance status 0 or 1
- patients who need breast biopsy as treatment for breast cancer.
You may not qualify if:
- nonpalpable breast tumor ≥ 5cm in patients with breast cancer.
- inflammatory cancer of breast or patients who need MRM
- 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
June 1, 2016
First Posted
June 29, 2016
Study Start
March 1, 2016
Primary Completion
September 1, 2016
Study Completion
December 1, 2016
Last Updated
June 29, 2016
Record last verified: 2016-06