Clinical Application of Near-infrared Fluorescence Guided... | NCT02172989

Studies
Clinical Application of Near-infrared Fluorescence Guided Localization on Breast Surgery in Benign Breast Neoplasm.

NCT02172989

Sponsor

National Cancer Center, Korea

Status

Completed

Last Update Posted

Jun 19, 2015Estimated

Enrollment

20Actual

Phase

Not provided

Conditions

Benign Breast Neoplasm

Interventions

Not provided

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

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2014

Primary Completion Date

Apr 2015Actual

Completion Date

May 2015Actual

First Submitted Date

Jun 23, 2014

First Submission Date that Met QC Criteria

Jun 23, 2014

First Posted Date

Jun 24, 2014Estimated

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 19, 2015Estimated

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

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

1 Week

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
non-palpable lesion localization rate	non-palpable lesion localization rate = number of patients complete excision of lesion / 20 enrolled patients	up to 6month

Secondary Outcomes

Measure	Description	Time Frame
lesion of resection size, completeness of resection	actual lesion of widthheightlength / resection lesion of widthheightlength	up to 6month

Other Outcomes

Measure	Description	Time Frame
physical assess	number of patients with pigmented skin lesion, number of patients with complication, number of patients with breast lymphedema, number of patients with residual breast lesion using breast ultrsound	following up a week to 6 month

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

nonpalpable benign breast lesion ≤ 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 benign breast lesion ≥ 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

nonpalpable benign breast lesion ≤ 2cm in patients with breast cancer.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

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		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