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

Breast Diseases Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04606329
• Other study ID #: HL_LMN_301
• Status: Completed
• Phase: Phase 3
• Start date: July 20, 2020
• Est. completion date: January 28, 2021

Study information

• Verified date: February 2021
• Source: Hanlim Pharm. Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 109
• Est. completion date: January 28, 2021
• Est. primary completion date: January 28, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Diseases

Intervention

Drug:
• LuminoMark inj.(Conc. for fluorescence)
Injection LuminoMark inj. (Conc. for fluorescence) 0.2mL once in this study.
• Charcotrace Inj.
Injection Charcotrace Inj. about 0.3~1mL once in this study.

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Hanlim Pharm. Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Negative Resection margin rate	The presence or absence of margin involvement in the resected breast lesions	Visit 5 (Day 14 ~Day 24)
Secondary	Technical success rate	The proportion of colored lesion when make an incision	Visit 3 (Day 0)
Secondary	Coloring confirmation rate of excision lesion	The proportion of colored excision lesion	Visit 3 (Day 0)
Secondary	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)
Secondary	Pigmentation rate	Check whether skin is pigmented or not	Visit 5 (Day 14 ~Day 24)
Secondary	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)
Secondary	Procedure complication rate	Evaluate the numbers of subjects with procedure complication after lesion removal	Visit 4, 5 (Day 1, Day 14 ~Day 24)