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To Evaluate the Efficacy and Safety of LuminoMark Injection in Patients With Nonpalpable Breast Lesions

Sponsor
Hanlim Pharm. Co., Ltd. (Industry)
Overall Status
Completed
CT.gov ID
NCT03743259
Collaborator
(none)
44
Enrollment
1
Location
3
Arms
10.8
Actual Duration (Months)
4.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study is a multicenter, Open-label, Parallel, Phase 2 Clinical Trial in 6 weeks for screening, once Investigational product injection, Follow up visit.

Condition or Disease Intervention/Treatment Phase
  • Drug: LuminoMark inj. 0.1mL
  • Drug: LuminoMark inj. 0.2mL
  • Drug: Charcotrace Inj.
 Phase 2

Detailed Description

The purpose of this study is to evaluate the efficacy and safety of LuminoMark inj. (Conc. for fluorescence) localization in patients with nonpalpable breast lesions.

Study Design

Study Type:
Interventional
Actual Enrollment :
44 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Multicenter, Open-label, Parallel, Phase 2 Clinical Trial to Evaluate the Efficacy and Safety of LuminoMark Inj. (Conc. for Fluorescence) Localization in Patients With Nonpalpable Breast Lesions
Actual Study Start Date :
May 29, 2018
Actual Primary Completion Date :
Jan 11, 2019
Actual Study Completion Date :
Apr 22, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: LuminoMark inj. 0.1mL

Injection LuminoMark inj. 0.1mL once in this study.

Drug: LuminoMark inj. 0.1mL
Injection LuminoMark inj. (Conc. for fluorescence) 0.1mL once in this study.
Other Names:
  • LuminoMark inj.(Conc. for fluorescence) 0.1mL

    		•
    Experimental: LuminoMark inj. 0.2mL

    Injection LuminoMark inj. 0.2mL once in this study.

    Drug: LuminoMark inj. 0.2mL
    Injection LuminoMark inj. (Conc. for fluorescence) 0.2mL once in this study.
    Other Names:
  • LuminoMark inj.(Conc. for fluorescence) 0.2mL

    		•
    Active Comparator: Charcotrace Inj.

    Charcotrace Inj. about 0.3~1mL

    Drug: Charcotrace Inj.
    Injection Charcotrace Inj. about 0.3~1mL once in this study.
    Other Names:
  • Charcotrace Injection(Activated Charcoal 40mg/1ml)

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Excision perfection(It is a formula. This formula's calculation method is as follows. [Excision perfection = the longest diameter of removed lesion after surgery / the longest diameter of identified lesion via breast ultrasonography results]) [Visit 3(Day 0)]

      Excision perfection is how well the surgeon removed the lesion compared to an identified by breast ultrasonography. Visit 3, Investigators calculate 'Excision perfection' using by the formula.

    Secondary Outcome Measures

    1. Coloring confirmation rate of excision lesion. [Visit 3(Day 0)]

      The proportion of colored excision lesion

    2. Technical success rate [Visit 3(Day 0)]

      The proportion of colored lesion when make an incision

    3. Pathologic perfection(It is a formula. This formula's calculation method is as follows. [Pathologic perfection = the longest diameter of measured lesion by gross(=visual) pathologic method / the longest diameter of removed lesion after surgery]) [Visit 3(Day 0)]

      Pathologic perfection is how well the surgeon removed the lesion compared to an identified by gross pathologic method. Visit 3, Investigators calculate 'Pathologic perfection' using by the formula.

    4. Pigmentation [Visit 5(Day 10~Day 24)]

      Check whether skin is pigmented or not

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years to 80 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Female, 19 years ≤ age ≥ 80 years

    2. Those who be expected to do operation about non palpable breast lesion excision

    3. Those who have lesion vial mammography and breast ultrasound

    4. Written consent voluntarily to participate in this clinical trial

    Exclusion Criteria:

    1. Patients who be expected to do mastectomy

    2. Patients with multiple tumor or diffuse microcalcification

    3. Patients who have ink on invasive cancer or ductal carcinoma in situ despite 3 times local resection

    4. Patients who were treated with moderate to severe radiotherapy

    5. Patients who were treated with neoadjuvant Chemotherapy

    6. Patients with active invading skin connective tissue disease

    7. Patients with local progressing breast cancer or inflammatory local progressing breast cancer

    8. Patients who have an allergy to investigational product or any of the component with the Investigational product

    9. Patients who disagree about contraception for this clinical trial

    10. A pregnant women or lactating women

    11. Patients who participated in other clinical trials within the past 12 weeks from the date of informed consent

    12. Patients who investigators determines unsuitable for this clinical trial

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Samsung Medical Center Seoul Korea, Republic of 06351

    Sponsors and Collaborators

    • Hanlim Pharm. Co., Ltd.

    Investigators

    • Principal Investigator: Seok Won Kim, PI, Samsung Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hanlim Pharm. Co., Ltd.
    ClinicalTrials.gov Identifier:
    NCT03743259
    Other Study ID Numbers:
    • HL_LMN_201
    First Posted:
    Nov 16, 2018
    Last Update Posted:
    Jun 6, 2019
    Last Verified:
    Jan 1, 2019
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Hanlim Pharm. Co., Ltd.
    Nonpalpable Breast Lesions
    Additional relevant MeSH terms:
    Breast Diseases
    Charcoal

    Study Results

    No Results Posted as of Jun 6, 2019