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

Benign Breast Neoplasm Clinical Trial

Official title:

Clinical Application of Near-infrared Fluorescence Guided Localization on Breast Surgery in Benign Breast Neoplasm ; Observational Pilot Study for 20 Patients.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02172989
• Other study ID #: NCC-1410202-1
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: June 23, 2014
• Last updated: June 17, 2015
• Start date: June 2014
• Est. completion date: May 2015

Study information

• Verified date: June 2015
• Source: National Cancer Center, Korea
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: National Cancer Center
• Study type: Observational [Patient Registry]

Clinical Trial 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: May 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 70 Years

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Benign Breast Neoplasm
• Breast Neoplasms
• Neoplasms

Locations

Country	Name	City	State
Korea, Republic of	National Cancer Center	Goyang-si	Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Center, Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	Yes
Primary	non-palpable lesion localization rate	non-palpable lesion localization rate = number of patients complete excision of lesion / 20 enrolled patients	up to 6month	Yes
Secondary	lesion of resection size, completeness of resection	actual lesion of width*height*length / resection lesion of width*height*length	up to 6month	Yes