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

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ClinicalTrials.gov Identifier: NCT02817334
Recruitment Status : Unknown
Verified June 2016 by So-Youn Jung, National Cancer Center, Korea.
Recruitment status was:  Recruiting
First Posted : June 29, 2016
Last Update Posted : June 29, 2016
Sponsor:
Information provided by (Responsible Party):
So-Youn Jung, National Cancer Center, Korea

Brief 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.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: indocyanine green Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 149 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective Clinical Study for Evaluation of Safe Resection Margin in Breast Conserving Surgery
Study Start Date : March 2016
Estimated Primary Completion Date : September 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: indocyanine green

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

Intervention: Drug: indocyanine green

Drug: indocyanine green
As inject only indocyanine green (ICG), it provide the surgeon visual guidance to ensure better outcome.
Other Name: Near-infrared fluorescence




Primary Outcome Measures :
  1. detection rate [ Time Frame: one day ]
    after complete resection with intraoperative ultrasound confirmed the lesion


Secondary Outcome Measures :
  1. determine the pathological stability [ Time Frame: one day ]
    determine the pathological stability with biopsy results confirmed during surgery


Other Outcome Measures:
  1. Side effects and availability Side effects and availability Side effects and availability side effects and availability [ Time Frame: following up a week to 3 month ]

    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.


  2. side effects and availability [ Time Frame: following up a week to 3 month ]
    After scanning, difficulty breathing, a decrease in blood pressure checked whether he had o reaction, such as anaphylactic shock.

  3. side effects ans availability [ Time Frame: following up a week to 3 month ]
    The skin discoloration, verify that there aren't stay in a follow-up after three months after surgery.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02817334


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    +82-31-920-1681    goje1@ncc.re.kr   
Principal Investigator: So-Youn Jung         
Sponsors and Collaborators
National Cancer Center, Korea
Investigators
Principal Investigator: So-Youn Jung National Cancer Center, Korea

Responsible Party: So-Youn Jung, Medical Doctor, National Cancer Center, Korea
ClinicalTrials.gov Identifier: NCT02817334     History of Changes
Other Study ID Numbers: NCC-1410202-3
First Posted: June 29, 2016    Key Record Dates
Last Update Posted: June 29, 2016
Last Verified: June 2016

Keywords provided by So-Youn Jung, National Cancer Center, Korea:
Near-infrared fluorescence
Indocyanine green, ICG
breast cancer

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