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

Phase 3

Completed

• Conditions: Breast Diseases
• Interventions: Drug: LuminoMark inj.(Conc. for fluorescence); Drug: Charcotrace Inj.

• Registration Number: NCT04606329
• Lead Sponsor: Hanlim Pharm. Co., Ltd.

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.

Study Timeline

• Study Start: 2020-07-20
• Study First Submitted: 2020-10-14
• Study First Submitted QC: 2020-10-26
• Study First Posted: 2020-10-28
• Primary Completion: 2021-01-28
• Study Completion: 2021-01-28
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-09
• Last Update Posted: 2021-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 109

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LuminoMark inj.	LuminoMark inj.(Conc. for fluorescence)	Injection LuminoMark inj. 0.2mL once in this study.
Charcotrace Inj.	Charcotrace Inj.	Charcotrace Inj. about 0.3\~1mL

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Pathologic perfection	Visit 5 (Day 14 ~Day 24)	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. \[Pathologic perfection = the longest diameter of measured lesion by gross(=visual) pathologic method / the longest diameter of removed lesion after surgery\]
Technical success rate	Visit 3 (Day 0)	The proportion of colored lesion when make an incision
Coloring confirmation rate of excision lesion	Visit 3 (Day 0)	The proportion of colored excision lesion
Pigmentation rate	Visit 5 (Day 14 ~Day 24)	Check whether skin is pigmented or not
Re-operation rate	Visit 5 (Day 14 ~Day 24)	The number of subjects who need re-operation is evaluated based on the investigator's comprehensive judgment including histopathology test results.
Procedure complication rate	Visit 4, 5 (Day 1, Day 14 ~Day 24)	Evaluate the numbers of subjects with procedure complication after lesion removal

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of