To Evaluate the Efficacy and Safety of LuminoMark Injection in Patients With Nonpalpable Breast Lesions(Phase 3)

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

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.

Study Overview

• Status: Completed
• Conditions: Breast Diseases
• Intervention / Treatment: Drug: LuminoMark inj.(Conc. for fluorescence); Drug: Charcotrace Inj.

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 Type: Interventional
• Enrollment (Actual): 109
• Phase: Phase 3

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 06351
    • Samsung Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. 19 years ≤ age ≥ 80 years
2. Those who have lesion vial mammography and breast ultrasound
3. Those who be expected to do operation about non palpable breast lesion excision
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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LuminoMark inj.; Injection LuminoMark inj. 0.2mL once in this study.	Drug: LuminoMark inj.(Conc. for fluorescence); Injection LuminoMark inj. (Conc. for fluorescence) 0.2mL once in this study.
Active Comparator: Charcotrace Inj.; Charcotrace Inj. about 0.3~1mL	Drug: Charcotrace Inj.; Injection Charcotrace Inj. about 0.3~1mL once in this study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Negative Resection margin rate	The presence or absence of margin involvement in the resected breast lesions	Visit 5 (Day 14 ~Day 24)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Technical success rate	The proportion of colored lesion when make an incision	Visit 3 (Day 0)
Coloring confirmation rate of excision lesion	The proportion of colored excision lesion	Visit 3 (Day 0)
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]	Visit 5 (Day 14 ~Day 24)
Pigmentation rate	Check whether skin is pigmented or not	Visit 5 (Day 14 ~Day 24)
Re-operation rate	The number of subjects who need re-operation is evaluated based on the investigator's comprehensive judgment including histopathology test results.	Visit 5 (Day 14 ~Day 24)
Procedure complication rate	Evaluate the numbers of subjects with procedure complication after lesion removal	Visit 4, 5 (Day 1, Day 14 ~Day 24)

Collaborators and Investigators

• Sponsor: Hanlim Pharm. Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): July 20, 2020
• Primary Completion (Actual): January 28, 2021
• Study Completion (Actual): January 28, 2021

Study Registration Dates

• First Submitted: October 14, 2020
• First Submitted That Met QC Criteria: October 26, 2020
• First Posted (Actual): October 28, 2020

Study Record Updates

• Last Update Posted (Actual): February 10, 2021
• Last Update Submitted That Met QC Criteria: February 9, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: Nonpalpable Breast Lesions
• Additional Relevant MeSH Terms: Skin Diseases; Breast Diseases
• Other Study ID Numbers: HL_LMN_301

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No