To Evaluate the Efficacy and Safety of LuminoMark Injection in Patients With Nonpalpable Breast Lesions

NCT03743259 | Completed Phase 2

• 1 other identifier: HL_LMN_201
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a multicenter, Open-label, Parallel, Phase 2 Clinical Trial in 6 weeks for screening, once Investigational product injection, Follow up visit.

Conditions

Breast Diseases

Keywords

Nonpalpable Breast Lesions

Outcome Measures

Primary Outcomes (1)

• Excision perfection(It is a formula. This formula's calculation method is as follows. [Excision perfection = the longest diameter of removed lesion after surgery / the longest diameter of identified lesion via breast ultrasonography results])

  Excision perfection is how well the surgeon removed the lesion compared to an identified by breast ultrasonography. Visit 3, Investigators calculate 'Excision perfection' using by the formula.

  Visit 3(Day 0)

Secondary Outcomes (4)

• Coloring confirmation rate of excision lesion.

  Visit 3(Day 0)

• Technical success rate

  Visit 3(Day 0)

• Pathologic perfection(It is a 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 3(Day 0)

• Pigmentation

  Visit 5(Day 10~Day 24)

Study Arms (3)

LuminoMark inj. 0.1mL

EXPERIMENTAL

Injection LuminoMark inj. 0.1mL once in this study.

Drug: LuminoMark inj. 0.1mL

LuminoMark inj. 0.2mL

EXPERIMENTAL

Injection LuminoMark inj. 0.2mL once in this study.

Drug: LuminoMark inj. 0.2mL

Charcotrace Inj.

ACTIVE COMPARATOR

Charcotrace Inj. about 0.3\~1mL

Drug: Charcotrace Inj.

Interventions

LuminoMark inj. 0.1mL DRUG

Injection LuminoMark inj. (Conc. for fluorescence) 0.1mL once in this study.

Also known as: LuminoMark inj.(Conc. for fluorescence) 0.1mL

LuminoMark inj. 0.1mL

LuminoMark inj. 0.2mL DRUG

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

Also known as: LuminoMark inj.(Conc. for fluorescence) 0.2mL

LuminoMark inj. 0.2mL

Charcotrace Inj. DRUG

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

Also known as: Charcotrace Injection(Activated Charcoal 40mg/1ml)

Charcotrace Inj.

Eligibility Criteria

• Age: 19 Years - 80 Years
• Gender Eligibility Details: Only female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female, 19 years ≤ age ≥ 80 years
• Those who be expected to do operation about non palpable breast lesion excision
• Those who have lesion vial mammography and breast ultrasound
• Written consent voluntarily to participate in this clinical trial

You may not qualify if:

• 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

Sponsors & Collaborators

• Hanlim Pharm. Co., Ltd.: lead

Study Sites (1)

Samsung Medical Center

Seoul, 06351, South Korea

Location

Related Publications (1)

• Kim I, Choi HJ, Ryu JM, Lee SK, Yu JH, Lee JE, Nam SJ, Shin HJ, Kim SW. The efficacy and safety of indocyanine green-hyaluronic acid mixture (LuminoMark) for localization in patients with non-palpable breast lesions: a multi-center open-label parallel phase-2 clinical trial. BMC Surg. 2021 Mar 16;21(1):134. doi: 10.1186/s12893-021-01129-y.

  PMID: 33726718 DERIVED

MeSH Terms

Conditions

Breast Diseases

Interventions

Fluorescence

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Luminescence; Light; Electromagnetic Radiation; Electromagnetic Phenomena; Magnetic Phenomena; Physical Phenomena; Optical Phenomena

Study Officials

• Seok Won Kim, PI

  Samsung Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 8, 2018
• First Posted: November 16, 2018
• Study Start: May 29, 2018
• Primary Completion: January 11, 2019
• Study Completion: April 22, 2019
• Last Updated: June 6, 2019

Record last verified: 2019-01

Locations

KR (1)