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OpenTrials
Completed

NCT Number: NCT03743259

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

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

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Key information

Conditions

Breast Diseases Skin Diseases Skin and Connective Tissue Diseases

Age range

19 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Samsung Medical Center

Seoul, 06351, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

LuminoMark inj. 0.1mL

Drug

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

Other names: LuminoMark inj.(Conc. for fluorescence) 0.1mL

LuminoMark inj. 0.2mL

Drug

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

Other names: LuminoMark inj.(Conc. for fluorescence) 0.2mL

Charcotrace Inj.

Drug

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

Other names: Charcotrace Injection(Activated Charcoal 40mg/1ml)

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])

    Time frame: Visit 3(Day 0)

    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.

Secondary outcomes

  1. Coloring confirmation rate of excision lesion.

    Time frame: Visit 3(Day 0)

    The proportion of colored excision lesion

  2. Technical success rate

    Time frame: Visit 3(Day 0)

    The proportion of colored lesion when make an incision

  3. 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])

    Time frame: Visit 3(Day 0)

    Pathologic perfection is how well the surgeon removed the lesion compared to an identified by gross pathologic method. Visit 3, Investigators calculate 'Pathologic perfection' using by the formula.

  4. Pigmentation

    Time frame: Visit 5(Day 10~Day 24)

    Check whether skin is pigmented or not

Sponsors and collaborators

Lead sponsor

Hanlim Pharm. Co., Ltd.

Industry

Registry information

Official study title

A Multicenter, Open-label, Parallel, Phase 2 Clinical Trial to Evaluate the Efficacy and Safety of LuminoMark Inj. (Conc. for Fluorescence) Localization in Patients With Nonpalpable Breast Lesions

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Nov 16, 2018
Registry last updated
Jun 6, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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