- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02473159
Clinical Application of Near-infrared Fluorescence Guided Localization on Breast Surgery in Breast Cancer
June 17, 2015 updated by: So-Youn Jung, National Cancer Center, Korea
Clinical Application of Near-infrared Fluorescence Guided Localization on Breast Surgery in Breast Cancer: Interventional Pilot Study for 5 Patients
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.
Study Overview
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.
Study Type
Interventional
Enrollment (Anticipated)
5
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: So-Youn Jung
- Phone Number: +82-31-920-1681
- Email: goje1@ncc.re.kr
Study Locations
-
-
Gyeonggi-do
-
Goyang-si, Gyeonggi-do, Korea, Republic of, 410-769
- Recruiting
- National Cancer Center
-
Contact:
- So-Youn Jung
- Phone Number: +82-31-920-1681
- Email: goje1@ncc.re.kr
-
Principal Investigator:
- So-Youn Jung
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- nonpalpable breast tumor ≥ 2cm in patients with breast cancer.
- pregnancy
- history of severe allergy to ICG(Indocyanine Green)
- iode hypersensitiveness
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: indocyanine green
As inject only indocyanine green (ICG), it provide the surgeon visual guidance to ensure better outcome.
|
As inject only indocyanine green (ICG), it provide the surgeon visual guidance to ensure better outcome.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
detection rate
Time Frame: one day
|
after complete resection with intraoperative ultrasound confirmed the lesion
|
one day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
determine the pathological stability
Time Frame: one day
|
determine the pathological stability with biopsy results confirmed during surgery
|
one day
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
detection rate and reoperation rate
Time Frame: participants will be followed for the duration of return to clinic, an expected average of 1 weeks
|
tumor detection rate and reoperation rate of resection margin
|
participants will be followed for the duration of return to clinic, an expected average of 1 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2015
Primary Completion (Anticipated)
December 1, 2015
Study Completion (Anticipated)
December 1, 2015
Study Registration Dates
First Submitted
May 8, 2015
First Submitted That Met QC Criteria
June 11, 2015
First Posted (Estimate)
June 16, 2015
Study Record Updates
Last Update Posted (Estimate)
June 18, 2015
Last Update Submitted That Met QC Criteria
June 17, 2015
Last Verified
June 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NCC-1410202-2
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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