NCT02172989

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:

  1. 1.As inject only indocyanine green (ICG), it provide the surgeon visual guidance to ensure better outcome.
  2. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2014

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2014

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

June 23, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 24, 2014

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

June 19, 2015

Status Verified

June 1, 2015

Enrollment Period

10 months

First QC Date

June 23, 2014

Last Update Submit

June 17, 2015

Conditions

Benign Breast Neoplasm

Keywords

Near-infrared fluorescenceIndocyanine green, ICGRadio-guided surgerybreast cancer

Outcome Measures

Primary Outcomes (1)

  • 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 (1)

  • lesion of resection size, completeness of resection

    up to 6month

Other Outcomes (1)

  • physical assess

    following up a week to 6 month

Eligibility Criteria

Age20 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • nonpalpable benign breast lesion ≥ 2cm in patients with breast cancer.
  • pregnancy
  • history of severe allergy to ICG(Indocyanine Green)
  • iode hypersensitiveness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Cancer Center

Goyang-si, Gyeonggi-do, 410-769, South Korea

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • So-Youn Jung

    National Cancer Center, Korea

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
1 Week
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Dotor

Study Record Dates

First Submitted

June 23, 2014

First Posted

June 24, 2014

Study Start

June 1, 2014

Primary Completion

April 1, 2015

Study Completion

May 1, 2015

Last Updated

June 19, 2015

Record last verified: 2015-06

Locations

KR(1)