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Completed

NCT Number: NCT02172989

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

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.

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Key information

Conditions

Benign Breast Neoplasm Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

20 year–70 year

Sex eligibility

Female

Study type

Observational

Primary location

National Cancer Center

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

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. non-palpable lesion localization rate

    Time frame: up to 6month

    non-palpable lesion localization rate = number of patients complete excision of lesion / 20 enrolled patients

Secondary outcomes

  1. lesion of resection size, completeness of resection

    Time frame: up to 6month

    actual lesion of width*height*length / resection lesion of width*height*length

Other outcomes

  1. physical assess

    Time frame: following up a week to 6 month

    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

Sponsors and collaborators

Lead sponsor

National Cancer Center, Korea

Other Gov

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jun 24, 2014
Registry last updated
Jun 19, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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