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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03743259
Recruitment Status : Completed
First Posted : November 16, 2018
Last Update Posted : June 6, 2019
Sponsor:
Information provided by (Responsible Party):
Hanlim Pharm. Co., Ltd.

Study Description
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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
Breast Diseases 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
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Study Type : Interventional  (Clinical Trial)
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 : January 11, 2019
Actual Study Completion Date : April 22, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Diseases

Arms and Interventions
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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 Name: 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 Name: 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 Name: Charcotrace Injection(Activated Charcoal 40mg/1ml)


Outcome Measures
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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]) [ Time Frame: 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. [ Time Frame: Visit 3(Day 0) ]
    The proportion of colored excision lesion

  2. Technical success rate [ Time Frame: 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]) [ Time Frame: 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 [ Time Frame: Visit 5(Day 10~Day 24) ]
    Check whether skin is pigmented or not


Eligibility Criteria
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Ages Eligible for Study:   19 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Only female
Accepts Healthy Volunteers:   No
Criteria

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
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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): NCT03743259


Locations
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Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of, 06351
Sponsors and Collaborators
Hanlim Pharm. Co., Ltd.
Investigators
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Principal Investigator: Seok Won Kim, PI Samsung Medical Center
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Hanlim Pharm. Co., Ltd.
ClinicalTrials.gov Identifier: NCT03743259    
Other Study ID Numbers: HL_LMN_201
First Posted: November 16, 2018    Key Record Dates
Last Update Posted: June 6, 2019
Last Verified: January 2019

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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:
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Breast Diseases
Skin Diseases
Charcoal
 Antidotes
Protective Agents
Physiological Effects of Drugs