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OpenTrials
Completed

NCT Number: NCT04606329

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

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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Key information

Conditions

Breast Diseases Skin Diseases Skin and Connective Tissue Diseases

Age range

19 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

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

  • 19 years ≤ age ≥ 80 years
  • Those who have lesion vial mammography and breast ultrasound
  • Those who be expected to do operation about non palpable breast lesion excision
  • 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.(Conc. for fluorescence)

Drug

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

Charcotrace Inj.

Drug

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

Primary outcomes

  1. Negative Resection margin rate

    Time frame: Visit 5 (Day 14 ~Day 24)

    The presence or absence of margin involvement in the resected breast lesions

Secondary outcomes

  1. Technical success rate

    Time frame: Visit 3 (Day 0)

    The proportion of colored lesion when make an incision

  2. Coloring confirmation rate of excision lesion

    Time frame: Visit 3 (Day 0)

    The proportion of colored excision lesion

  3. Pathologic perfection

    Time frame: 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]

  4. Pigmentation rate

    Time frame: Visit 5 (Day 14 ~Day 24)

    Check whether skin is pigmented or not

  5. Re-operation rate

    Time frame: 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.

  6. Procedure complication rate

    Time frame: Visit 4, 5 (Day 1, Day 14 ~Day 24)

    Evaluate the numbers of subjects with procedure complication after lesion removal

Sponsors and collaborators

Lead sponsor

Hanlim Pharm. Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Oct 28, 2020
Registry last updated
Feb 10, 2021

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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