NCT04606329

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
109

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jul 2020

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 20, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 14, 2020

Completed
14 days until next milestone

First Posted

Study publicly available on registry

October 28, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 28, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 28, 2021

Completed
Last Updated

February 10, 2021

Status Verified

February 1, 2021

Enrollment Period

6 months

First QC Date

October 14, 2020

Last Update Submit

February 9, 2021

Conditions

Breast Diseases

Keywords

Nonpalpable Breast Lesions

Outcome Measures

Primary Outcomes (1)

  • Negative Resection margin rate

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

    Visit 5 (Day 14 ~Day 24)

Secondary Outcomes (6)

  • Technical success rate

    Visit 3 (Day 0)

  • Coloring confirmation rate of excision lesion

    Visit 3 (Day 0)

  • Pathologic perfection

    Visit 5 (Day 14 ~Day 24)

  • Pigmentation rate

    Visit 5 (Day 14 ~Day 24)

  • Re-operation rate

    Visit 5 (Day 14 ~Day 24)

  • +1 more secondary outcomes

Study Arms (2)

LuminoMark inj.

EXPERIMENTAL

Injection LuminoMark inj. 0.2mL once in this study.

Drug: LuminoMark inj.(Conc. for fluorescence)

Charcotrace Inj.

ACTIVE COMPARATOR

Charcotrace Inj. about 0.3\~1mL

Drug: Charcotrace Inj.

Interventions

LuminoMark inj.(Conc. for fluorescence)DRUG

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

LuminoMark inj.
Charcotrace Inj.DRUG

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

Charcotrace Inj.

Eligibility Criteria

Age19 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center

Seoul, 06351, South Korea

Location

MeSH Terms

Conditions

Breast Diseases

Interventions

Fluorescence

Condition Hierarchy (Ancestors)

Skin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

LuminescenceLightElectromagnetic RadiationElectromagnetic PhenomenaMagnetic PhenomenaPhysical PhenomenaOptical Phenomena

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 14, 2020

First Posted

October 28, 2020

Study Start

July 20, 2020

Primary Completion

January 28, 2021

Study Completion

January 28, 2021

Last Updated

February 10, 2021

Record last verified: 2021-02

Locations

KR(1)