Clinical Application of Near-infrared Fluorescence Guided Localization on Breast Surgery in Breast Cancer

NCT ID: NCT02473159

Last Updated: 2015-06-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

Study Completion Date

2015-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Breast Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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indocyanine green

As inject only indocyanine green (ICG), it provide the surgeon visual guidance to ensure better outcome.

Group Type EXPERIMENTAL

indocyanine green

Intervention Type DRUG

As inject only indocyanine green (ICG), it provide the surgeon visual guidance to ensure better outcome.

Interventions

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indocyanine green

As inject only indocyanine green (ICG), it provide the surgeon visual guidance to ensure better outcome.

Intervention Type DRUG

Other Intervention Names

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Near-infrared fluorescence

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Center, Korea

OTHER_GOV

Sponsor Role lead

Responsible Party

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So-Youn Jung

Medical Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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So-Youn Jung

Role: PRINCIPAL_INVESTIGATOR

National Cancer Center, Korea

Locations

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National Cancer Center

Goyang-si, Gyeonggi-do, South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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So-Youn Jung

Role: CONTACT

+82-31-920-1681

Facility Contacts

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So-Youn Jung

Role: primary

+82-31-920-1681

Other Identifiers

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NCC-1410202-2

Identifier Type: -

Identifier Source: org_study_id

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