Back to resultsTo Evaluate the Efficacy and Safety of LuminoMark Injection in Patients With Nonpalpable Breast Lesions(Phase 3)
Primary Purpose
Breast Diseases
Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
LuminoMark inj.(Conc. for fluorescence)
Charcotrace Inj.
Sponsored by
About this trial
This is an interventional treatment trial for Breast Diseases focused on measuring Nonpalpable Breast Lesions
Eligibility Criteria
Inclusion Criteria:
- 19 years ≤ age ≥ 80 years
- Those who have lesion vial mammography and breast ultrasound
- Those who be expected to do operation about non palpable breast lesion excision
- 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
Sites / Locations
- Samsung Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
LuminoMark inj.
Charcotrace Inj.
Arm Description
Injection LuminoMark inj. 0.2mL once in this study.
Charcotrace Inj. about 0.3~1mL
Outcomes
Primary Outcome Measures
Negative Resection margin rate
The presence or absence of margin involvement in the resected breast lesions
Secondary Outcome Measures
Technical success rate
The proportion of colored lesion when make an incision
Coloring confirmation rate of excision lesion
The proportion of colored excision lesion
Pathologic perfection
Pathologic perfection is how well the surgeon removed the lesion compared to an identified by gross pathologic method. Visit 5, Investigators calculate 'Pathologic perfection' using by the 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]
Pigmentation rate
Check whether skin is pigmented or not
Re-operation rate
The number of subjects who need re-operation is evaluated based on the investigator's comprehensive judgment including histopathology test results.
Procedure complication rate
Evaluate the numbers of subjects with procedure complication after lesion removal
Full Information
NCT ID
NCT04606329
First Posted
October 14, 2020
Last Updated
February 9, 2021
Sponsor
Hanlim Pharm. Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT04606329
Brief Title
To Evaluate the Efficacy and Safety of LuminoMark Injection in Patients With Nonpalpable Breast Lesions(Phase 3)
Official Title
A Multicenter, Randomized, Open-label, Parallel Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of LuminoMark Inj. Versus Charcotrace Inj. in Patients With Nonpalpable Breast Lesions
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
July 20, 2020 (Actual)
Primary Completion Date
January 28, 2021 (Actual)
Study Completion Date
January 28, 2021 (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, Randomized, Open-label, Parallel, Phase 3 Clinical Trial in 8 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 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
109 (Actual)
8. Arms, Groups, and Interventions
Arm Title
LuminoMark inj.
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.(Conc. for fluorescence)
Intervention Description
Injection LuminoMark inj. (Conc. for fluorescence) 0.2mL once in this study.
Intervention Type
Drug
Intervention Name(s)
Charcotrace Inj.
Intervention Description
Injection Charcotrace Inj. about 0.3~1mL once in this study.
Primary Outcome Measure Information:
Title
Negative Resection margin rate
Description
The presence or absence of margin involvement in the resected breast lesions
Time Frame
Visit 5 (Day 14 ~Day 24)
Secondary Outcome Measure Information:
Title
Technical success rate
Description
The proportion of colored lesion when make an incision
Time Frame
Visit 3 (Day 0)
Title
Coloring confirmation rate of excision lesion
Description
The proportion of colored excision lesion
Time Frame
Visit 3 (Day 0)
Title
Pathologic perfection
Description
Pathologic perfection is how well the surgeon removed the lesion compared to an identified by gross pathologic method. Visit 5, Investigators calculate 'Pathologic perfection' using by the 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 5 (Day 14 ~Day 24)
Title
Pigmentation rate
Description
Check whether skin is pigmented or not
Time Frame
Visit 5 (Day 14 ~Day 24)
Title
Re-operation rate
Description
The number of subjects who need re-operation is evaluated based on the investigator's comprehensive judgment including histopathology test results.
Time Frame
Visit 5 (Day 14 ~Day 24)
Title
Procedure complication rate
Description
Evaluate the numbers of subjects with procedure complication after lesion removal
Time Frame
Visit 4, 5 (Day 1, Day 14 ~Day 24)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
19 years ≤ age ≥ 80 years
Those who have lesion vial mammography and breast ultrasound
Those who be expected to do operation about non palpable breast lesion excision
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
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
To Evaluate the Efficacy and Safety of LuminoMark Injection in Patients With Nonpalpable Breast Lesions(Phase 3)
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