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

Primary Purpose

Breast Diseases

Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
LuminoMark inj. 0.1mL
LuminoMark inj. 0.2mL
Charcotrace Inj.
Sponsored by
Hanlim Pharm. Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Diseases focused on measuring Nonpalpable Breast Lesions

Eligibility Criteria

19 Years - 80 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Samsung Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

LuminoMark inj. 0.1mL

LuminoMark inj. 0.2mL

Charcotrace Inj.

Arm Description

Injection LuminoMark inj. 0.1mL once in this study.

Injection LuminoMark inj. 0.2mL once in this study.

Charcotrace Inj. about 0.3~1mL

Outcomes

Primary Outcome Measures

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])
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

Coloring confirmation rate of excision lesion.
The proportion of colored excision lesion
Technical success rate
The proportion of colored lesion when make an incision
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])
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.
Pigmentation
Check whether skin is pigmented or not

Full Information

First Posted
November 8, 2018
Last Updated
June 5, 2019
Sponsor
Hanlim Pharm. Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT03743259
Brief Title
To Evaluate the Efficacy and Safety of LuminoMark Injection in Patients With Nonpalpable Breast Lesions
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
May 29, 2018 (Actual)
Primary Completion Date
January 11, 2019 (Actual)
Study Completion Date
April 22, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hanlim Pharm. Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Diseases
Keywords
Nonpalpable Breast Lesions

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
LuminoMark inj. 0.1mL
Arm Type
Experimental
Arm Description
Injection LuminoMark inj. 0.1mL once in this study.
Arm Title
LuminoMark inj. 0.2mL
Arm Type
Experimental
Arm Description
Injection LuminoMark inj. 0.2mL once in this study.
Arm Title
Charcotrace Inj.
Arm Type
Active Comparator
Arm Description
Charcotrace Inj. about 0.3~1mL
Intervention Type
Drug
Intervention Name(s)
LuminoMark inj. 0.1mL
Other Intervention Name(s)
LuminoMark inj.(Conc. for fluorescence) 0.1mL
Intervention Description
Injection LuminoMark inj. (Conc. for fluorescence) 0.1mL once in this study.
Intervention Type
Drug
Intervention Name(s)
LuminoMark inj. 0.2mL
Other Intervention Name(s)
LuminoMark inj.(Conc. for fluorescence) 0.2mL
Intervention Description
Injection LuminoMark inj. (Conc. for fluorescence) 0.2mL once in this study.
Intervention Type
Drug
Intervention Name(s)
Charcotrace Inj.
Other Intervention Name(s)
Charcotrace Injection(Activated Charcoal 40mg/1ml)
Intervention Description
Injection Charcotrace Inj. about 0.3~1mL once in this study.
Primary Outcome Measure Information:
Title
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])
Description
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.
Time Frame
Visit 3(Day 0)
Secondary Outcome Measure Information:
Title
Coloring confirmation rate of excision lesion.
Description
The proportion of colored excision lesion
Time Frame
Visit 3(Day 0)
Title
Technical success rate
Description
The proportion of colored lesion when make an incision
Time Frame
Visit 3(Day 0)
Title
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])
Description
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.
Time Frame
Visit 3(Day 0)
Title
Pigmentation
Description
Check whether skin is pigmented or not
Time Frame
Visit 5(Day 10~Day 24)

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Only female
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Female, 19 years ≤ age ≥ 80 years Those who be expected to do operation about non palpable breast lesion excision Those who have lesion vial mammography and breast ultrasound Written consent voluntarily to participate in this clinical trial Exclusion Criteria: Patients who be expected to do mastectomy Patients with multiple tumor or diffuse microcalcification Patients who have ink on invasive cancer or ductal carcinoma in situ despite 3 times local resection Patients who were treated with moderate to severe radiotherapy Patients who were treated with neoadjuvant Chemotherapy Patients with active invading skin connective tissue disease Patients with local progressing breast cancer or inflammatory local progressing breast cancer Patients who have an allergy to investigational product or any of the component with the Investigational product Patients who disagree about contraception for this clinical trial A pregnant women or lactating women Patients who participated in other clinical trials within the past 12 weeks from the date of informed consent Patients who investigators determines unsuitable for this clinical trial
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Seok Won Kim, PI
Organizational Affiliation
Samsung Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
33726718
Citation
Kim I, Choi HJ, Ryu JM, Lee SK, Yu JH, Lee JE, Nam SJ, Shin HJ, Kim SW. The efficacy and safety of indocyanine green-hyaluronic acid mixture (LuminoMark) for localization in patients with non-palpable breast lesions: a multi-center open-label parallel phase-2 clinical trial. BMC Surg. 2021 Mar 16;21(1):134. doi: 10.1186/s12893-021-01129-y.
Results Reference
derived

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

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