Back to resultsA Prospective Clinical Study for Evaluation of Safe Resection Margin in Breast Conserving Surgery in Breast Cancer
Primary Purpose
Breast Cancer
Status
Unknown status
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
indocyanine green
Sponsored by
About this trial
This is an interventional treatment trial for Breast Cancer focused on measuring Near-infrared fluorescence, Indocyanine green, ICG, breast cancer
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Sites / Locations
- National Cancer CenterRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
indocyanine green
Arm Description
As inject only indocyanine green (ICG), it provide the surgeon visual guidance to ensure better outcome. Intervention: Drug: indocyanine green
Outcomes
Primary Outcome Measures
detection rate
after complete resection with intraoperative ultrasound confirmed the lesion
Secondary Outcome Measures
determine the pathological stability
determine the pathological stability with biopsy results confirmed during surgery
Full Information
NCT ID
NCT02817334
First Posted
June 1, 2016
Last Updated
June 26, 2016
Sponsor
National Cancer Center, Korea
1. Study Identification
Unique Protocol Identification Number
NCT02817334
Brief Title
A Prospective Clinical Study for Evaluation of Safe Resection Margin in Breast Conserving Surgery in Breast Cancer
Official Title
A Prospective Clinical Study for Evaluation of Safe Resection Margin in Breast Conserving Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
June 2016
Overall Recruitment Status
Unknown status
Study Start Date
March 2016 (undefined)
Primary Completion Date
September 2016 (Anticipated)
Study Completion Date
December 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Cancer Center, Korea
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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:
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Near-infrared fluorescence, Indocyanine green, ICG, breast cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
149 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
indocyanine green
Arm Type
Experimental
Arm Description
As inject only indocyanine green (ICG), it provide the surgeon visual guidance to ensure better outcome.
Intervention: Drug: indocyanine green
Intervention Type
Drug
Intervention Name(s)
indocyanine green
Other Intervention Name(s)
Near-infrared fluorescence
Intervention Description
As inject only indocyanine green (ICG), it provide the surgeon visual guidance to ensure better outcome.
Primary Outcome Measure Information:
Title
detection rate
Description
after complete resection with intraoperative ultrasound confirmed the lesion
Time Frame
one day
Secondary Outcome Measure Information:
Title
determine the pathological stability
Description
determine the pathological stability with biopsy results confirmed during surgery
Time Frame
one day
Other Pre-specified Outcome Measures:
Title
Side effects and availability Side effects and availability Side effects and availability side effects and availability
Description
Itchiness, erythema, rash and other allergic reactions there could have shots later.
Itchiness, erythema, rash and other allergic reactions there could have shots later.
Itchiness, erythema, rash and other allergic reactions there could have shots later.
Itchiness, erythema, rash and other allergic reactions there could have shots later.
Time Frame
following up a week to 3 month
Title
side effects and availability
Description
After scanning, difficulty breathing, a decrease in blood pressure checked whether he had o reaction, such as anaphylactic shock.
Time Frame
following up a week to 3 month
Title
side effects ans availability
Description
The skin discoloration, verify that there aren't stay in a follow-up after three months after surgery.
Time Frame
following up a week to 3 month
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
So-Youn Jung
Phone
+82-31-920-1681
Email
goje1@ncc.re.kr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
So-Youn Jung
Organizational Affiliation
National Cancer Center, Korea
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Cancer Center
City
Goyang-si
State/Province
Gyeonggi-do
ZIP/Postal Code
410-769
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
So-Youn Jung
Phone
+82-31-920-1681
Email
goje1@ncc.re.kr
First Name & Middle Initial & Last Name & Degree
So-Youn Jung
12. IPD Sharing Statement
Learn more about this trial
A Prospective Clinical Study for Evaluation of Safe Resection Margin in Breast Conserving Surgery in Breast Cancer
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