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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by National Cancer Center, Korea
Sponsor:
Information provided by (Responsible Party):
So-Youn Jung, National Cancer Center, Korea
ClinicalTrials.gov Identifier:
NCT02172989
First received: June 23, 2014
Last updated: June 24, 2014
Last verified: June 2014
  Purpose

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.

Condition Phase
Benign Breast Neoplasm
Phase 1
Phase 2

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 1 Week
Official Title: Clinical Application of Near-infrared Fluorescence Guided Localization on Breast Surgery in Benign Breast Neoplasm ; Observational Pilot Study for 20 Patients.

Resource links provided by NLM:


Further study details as provided by National Cancer Center, Korea:

Primary Outcome Measures:
  • non-palpable lesion localization rate [ Time Frame: up to 6month ] [ Designated as safety issue: Yes ]
    non-palpable lesion localization rate = number of patients complete excision of lesion / 20 enrolled patients


Secondary Outcome Measures:
  • lesion of resection size, completeness of resection [ Time Frame: up to 6month ] [ Designated as safety issue: Yes ]
    actual lesion of width*height*length / resection lesion of width*height*length


Other Outcome Measures:
  • physical assess [ Time Frame: following up a week to 6 month ] [ Designated as safety issue: Yes ]
    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


Estimated Enrollment: 20
Study Start Date: June 2014
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Detailed 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.
  Eligibility

Ages Eligible for Study:   20 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02172989

Contacts
Contact: So-Youn Jung +82-31-920-1681 goje1@ncc.re.kr

Locations
Korea, Republic of
National Cancer Center Recruiting
Goyang-si, Gyeonggi-do, Korea, Republic of, 410-769
Contact: So-Youn Jung    +82-31-901-1681 ext 1681    goje1@ncc.re.kr   
Sponsors and Collaborators
National Cancer Center, Korea
Investigators
Principal Investigator: So-Youn Jung National Cancer Center, Korea
  More Information

No publications provided

Responsible Party: So-Youn Jung, Medical Dotor, National Cancer Center, Korea
ClinicalTrials.gov Identifier: NCT02172989     History of Changes
Other Study ID Numbers: NCC-1410202-1
Study First Received: June 23, 2014
Last Updated: June 24, 2014
Health Authority: Korea: National Cancer Center

Keywords provided by National Cancer Center, Korea:
Near-infrared fluorescence
Indocyanine green, ICG
Radio-guided surgery
breast cancer

Additional relevant MeSH terms:
Neoplasms
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on September 16, 2014