A Prospective Clinical Study for Evaluation of Safe Resection Margin in Breast Conserving Surgery in Breast Cancer

Breast Cancer Clinical Trial

Official title:

A Prospective Clinical Study for Evaluation of Safe Resection Margin in Breast Conserving Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02817334
• Other study ID #: NCC-1410202-3
• Status: Recruiting
• Phase: Phase 2
• First received: June 1, 2016
• Last updated: June 26, 2016
• Start date: March 2016
• Est. completion date: December 2016

Study information

• Verified date: June 2016
• 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: 149
• Est. completion date: December 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• nonpalpable breast tumor < 5cm in patients with breast cancer.

• consented patients with more than 18 years

• Eastern Cooperative Oncology Group Performance status 0 or 1

• patients who need breast biopsy as treatment for breast cancer.

Exclusion Criteria:

• nonpalpable breast tumor = 5cm in patients with breast cancer.

• inflammatory cancer of breast or patients who need MRM

• 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	Side effects and availability Side effects and availability Side effects and availability side effects and availability	Itchiness, erythema, rash and other allergic reactions there could have shots later.; Itchiness, erythema, rash and other allergic reactions there could have shots later.; Itchiness, erythema, rash and other allergic reactions there could have shots later.; Itchiness, erythema, rash and other allergic reactions there could have shots later.	following up a week to 3 month	No
Other	side effects and availability	After scanning, difficulty breathing, a decrease in blood pressure checked whether he had o reaction, such as anaphylactic shock.	following up a week to 3 month	No
Other	side effects ans availability	The skin discoloration, verify that there aren't stay in a follow-up after three months after surgery.	following up a week to 3 month	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