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CompletedNCT03743259Updated Jun 6, 2019

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

A Phase 2 interventional study of LuminoMark inj. 0.1mL and LuminoMark inj. 0.2mL in Breast Diseases, sponsored by Hanlim Pharm. Co., Ltd.. Completed at 1 site in Korea, Republic of. Open to female participants aged 19 Years to 80 Years. Per ClinicalTrials.gov, last updated 2019-06-06.

Sponsored by Hanlim Pharm. Co., Ltd. · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Registered 5 months after the study started (first participant enrolled May 2018, registered Nov 2018).
Phase
Phase 2
Study type
Interventional
Enrollment
44
Allocation
Non-randomized
Ages
19 Years to 80 Years
Sex
Female
01

Study 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.

Read the detailed 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.

02

Conditions studied

  • Breast Diseases

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Keywords

  • Nonpalpable Breast Lesions
03

In context

Breast Diseases

149 studies on the registry are indexed under Breast Diseases; 25 are open to participants now.

This study's enrollment of 44 is below the median of 123 across 92 interventional studies indexed under Breast Diseases.

Browse Breast Diseases studies →

Lead sponsor

Hanlim Pharm. Co., Ltd. is the lead sponsor of 49 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years to 80 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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
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Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
44 participants (actual)

Study arms

  • Experimental
    LuminoMark inj. 0.1mL

    Injection LuminoMark inj. 0.1mL once in this study.

    Drug: LuminoMark inj. 0.1mL

  • Experimental
    LuminoMark inj. 0.2mL

    Injection LuminoMark inj. 0.2mL once in this study.

    Drug: LuminoMark inj. 0.2mL

  • Active comparator
    Charcotrace Inj.

    Charcotrace Inj. about 0.3\~1mL

    Drug: Charcotrace Inj.

Interventions

  • DrugLuminoMark inj. 0.1mL

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

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

  • DrugLuminoMark inj. 0.2mL

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

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

  • DrugCharcotrace Inj.

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

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

06

What researchers measure

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.

    Time frame: Visit 3(Day 0)

Secondary outcomes

  1. Coloring confirmation rate of excision lesion.

    The proportion of colored excision lesion

    Time frame: Visit 3(Day 0)

  2. Technical success rate

    The proportion of colored lesion when make an incision

    Time frame: Visit 3(Day 0)

  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])

    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.

    Time frame: Visit 3(Day 0)

  4. Pigmentation

    Check whether skin is pigmented or not

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

07

Study locations

1 site
  • Samsung Medical Center
    Seoul, 06351, Korea, Republic of
08

References and documents

Publications

  • 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. PubMed 33726718 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 6, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03743259
Lead sponsor
Hanlim Pharm. Co., Ltd.
Responsible party
Sponsor
First posted
Nov 16, 2018
Start date
May 29, 2018
Primary completion
Jan 11, 2019
Completion
Apr 22, 2019
Last update
Jun 6, 2019

Study contacts

Seok Won Kim, PI
principal investigator · Samsung Medical Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.

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