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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

109 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-20

Study Completion Date

2021-01-28

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Breast Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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LuminoMark inj.

Injection LuminoMark inj. 0.2mL once in this study.

Group Type EXPERIMENTAL

LuminoMark inj.(Conc. for fluorescence)

Intervention Type DRUG

Injection LuminoMark inj. (Conc. for fluorescence) 0.2mL once in this study.

Charcotrace Inj.

Charcotrace Inj. about 0.3\~1mL

Group Type ACTIVE_COMPARATOR

Charcotrace Inj.

Intervention Type DRUG

Injection Charcotrace Inj. about 0.3\~1mL once in this study.

Interventions

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LuminoMark inj.(Conc. for fluorescence)

Injection LuminoMark inj. (Conc. for fluorescence) 0.2mL once in this study.

Intervention Type DRUG

Charcotrace Inj.

Injection Charcotrace Inj. about 0.3\~1mL once in this study.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

19 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No