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

June 5, 2019 updated by: Hanlim Pharm. Co., Ltd.

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

44

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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:

  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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Charcotrace Inj.
Charcotrace Inj. about 0.3~1mL
Drug: Charcotrace Inj.
Injection Charcotrace Inj. about 0.3~1mL once in this study.
Other Names:
  • Charcotrace Injection(Activated Charcoal 40mg/1ml)
Experimental: LuminoMark inj. 0.1mL
Injection LuminoMark inj. 0.1mL once in this study.
Drug: LuminoMark inj. 0.1mL
Injection LuminoMark inj. (Conc. for fluorescence) 0.1mL once in this study.
Other Names:
  • LuminoMark inj.(Conc. for fluorescence) 0.1mL
Experimental: LuminoMark inj. 0.2mL
Injection LuminoMark inj. 0.2mL once in this study.
Drug: LuminoMark inj. 0.2mL
Injection LuminoMark inj. (Conc. for fluorescence) 0.2mL once in this study.
Other Names:
  • LuminoMark inj.(Conc. for fluorescence) 0.2mL

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Visit 3(Day 0)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Coloring confirmation rate of excision lesion.
Time Frame: Visit 3(Day 0)
The proportion of colored excision lesion
Visit 3(Day 0)
Technical success rate
Time Frame: Visit 3(Day 0)
The proportion of colored lesion when make an incision
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])
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.
Visit 3(Day 0)
Pigmentation
Time Frame: Visit 5(Day 10~Day 24)
Check whether skin is pigmented or not
Visit 5(Day 10~Day 24)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hanlim Pharm. Co., Ltd.

Investigators

  • Principal Investigator: Seok Won Kim, PI, Samsung Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 29, 2018

Primary Completion (Actual)

January 11, 2019

Study Completion (Actual)

April 22, 2019

Study Registration Dates

First Submitted

November 8, 2018

First Submitted That Met QC Criteria

November 13, 2018

First Posted (Actual)

November 16, 2018

Study Record Updates

Last Update Posted (Actual)

June 6, 2019

Last Update Submitted That Met QC Criteria

June 5, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HL_LMN_201

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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