Clinical Application of Near-infrared Fluorescence Guided... | NCT02473159

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

NCT02473159

Sponsor

National Cancer Center, Korea

Status

Unknown status

Last Update Posted

Jun 18, 2015Estimated

Enrollment

5Estimated

Phase

Phase 2

Conditions

Breast Cancer

Interventions

indocyanine green

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2015

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2015

Primary Completion Date

Dec 2015Estimated

Completion Date

Dec 2015Estimated

First Submitted Date

May 8, 2015

First Submission Date that Met QC Criteria

Jun 11, 2015

First Posted Date

Jun 16, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 17, 2015

Last Update Posted Date

Jun 18, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

So-Youn Jung, Medical Doctor, National Cancer Center, KoreaPrincipal Investigator

Lead Sponsor

National Cancer Center, KoreaOTHER_GOV

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

5Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
indocyanine green	Experimental	As inject only indocyanine green (ICG), it provide the surgeon visual guidance to ensure better outcome.	Drug: indocyanine green

Interventions

Name	Type	Description	Arm Group Labels	Other Names
indocyanine green	Drug	As inject only indocyanine green (ICG), it provide the surgeon visual guidance to ensure better outcome.	indocyanine green

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
detection rate	after complete resection with intraoperative ultrasound confirmed the lesion	one day

Secondary Outcomes

Measure	Description	Time Frame
determine the pathological stability	determine the pathological stability with biopsy results confirmed during surgery	one day

Other Outcomes

Measure	Description	Time Frame
detection rate and reoperation rate	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

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
So-Youn Jung	Contact	+82-31-920-1681		goje1@ncc.re.kr

Overall Officials

Name	Affiliation	Role
So-Youn Jung	National Cancer Center, Korea	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
National Cancer Center	Recruiting	Goyang-si	Gyeonggi-do	410-769	South Korea

Condition Browse Module

MeSH Terms

ID	Term
D001943	Breast Neoplasms

Ancestor Terms

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D007208	Indocyanine Green

Ancestor Terms

ID	Term
D007211	Indoles
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D006571	Heterocyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided