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

Breast Cancer Clinical Trial

Official title:

Clinical Application of Near-infrared Fluorescence Guided Localization on Breast Surgery in Breast Cancer: Interventional Pilot Study for 5 Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02473159
• Other study ID #: NCC-1410202-2
• Status: Recruiting
• Phase: Phase 2
• First received: May 8, 2015
• Last updated: June 17, 2015
• Start date: March 2015
• Est. completion date: December 2015

Study information

• Verified date: June 2015
• Source: National Cancer Center, Korea
• Contact: So-Youn Jung
• Phone: +82-31-920-1681
• Email: goje1[@]ncc.re.kr
• Is FDA regulated: No
• Health authority: Korea: National Cancer Center
• Study type: Interventional

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: Recruiting
• Enrollment: 5
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 70 Years

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

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

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	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	No
Primary	detection rate	after complete resection with intraoperative ultrasound confirmed the lesion	one day	No
Secondary	determine the pathological stability	determine the pathological stability with biopsy results confirmed during surgery	one day	No