Breast DiseasesPhase 2NCT03743259

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

A Phase 2 study testing LuminoMark inj. 0.1mL, LuminoMark inj. 0.2mL and Charcotrace Inj. in people with Breast Diseases, run by Hanlim Pharm. Co., Ltd. at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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 more about this study

Who is it for?: Ages 19 to 80 years, women only
Conditions the study is for: Breast Diseases
What is being tested?: LuminoMark inj. 0.1mL, LuminoMark inj. 0.2mL and Charcotrace Inj.
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 44 participants
Where: 1 siteSouth Korea
Study dates: 29 May 2018to 22 Apr 2019
Phase: Phase 2
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 19 to 80 years
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

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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

Trial locations and contacts

1 site in 1 country.

South Korea1 site

Samsung Medical Center
Seoul, 06351

Other trials in South Korea

About this study

Official 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

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.

Conditions: Breast Diseases
Being tested: LuminoMark inj. 0.1mL, LuminoMark inj. 0.2mL, Charcotrace Inj.
Keywords: Nonpalpable Breast Lesions
Medical subject headings: Breast Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

LuminoMark inj. 0.1mLDrug
Also called LuminoMark inj.(Conc. for fluorescence) 0.1mL
Injection LuminoMark inj. (Conc. for fluorescence) 0.1mL once in this study.
LuminoMark inj. 0.2mLDrug
Also called LuminoMark inj.(Conc. for fluorescence) 0.2mL
Injection LuminoMark inj. (Conc. for fluorescence) 0.2mL once in this study.
Charcotrace Inj.Drug
Also called Charcotrace Injection(Activated Charcoal 40mg/1ml)
Injection Charcotrace Inj. about 0.3~1mL once in this study.

Study groups in NCT03743259
Study group	Role	What they receive
LuminoMark inj. 0.1mL	Experimental	Injection LuminoMark inj. 0.1mL once in this study. Receives: Drug: LuminoMark inj. 0.1mL
LuminoMark inj. 0.2mL	Experimental	Injection LuminoMark inj. 0.2mL once in this study. Receives: Drug: LuminoMark inj. 0.2mL
Charcotrace Inj.	Active comparator	Charcotrace Inj. about 0.3~1mL Receives: Drug: Charcotrace Inj.

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Visit 3(Day 0)

Secondary outcomes (4)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

29 May 201822 Apr 2019

First posted16 Nov 2018
Study start29 May 2018
Primary completion11 Jan 2019
Study completion22 Apr 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Breast DiseasesStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 44 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03743259
Sponsor's protocol ID: HL_LMN_201
Status last verified: Jan 2019
First submitted: 8 Nov 2018
Last updated: 6 Jun 2019
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 6 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official 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
ClinicalTrials.gov ID: NCT03743259
Acronym / sponsor ID: HL_LMN_201
Conditions: Breast Diseases
Keywords: Nonpalpable Breast Lesions
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 44 participants (actual)
Lead sponsor: Hanlim Pharm. Co., Ltd.Industry (pharma, biotech, devices)
Study start: 29 May 2018 (actual)
Primary completion: 11 Jan 2019 (actual)
Study completion: 22 Apr 2019 (actual)
First posted: 16 Nov 2018 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

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 design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
LuminoMark inj. 0.1mL	Experimental	Drug: LuminoMark inj. 0.1mLInjection LuminoMark inj. 0.1mL once in this study.
LuminoMark inj. 0.2mL	Experimental	Drug: LuminoMark inj. 0.2mLInjection LuminoMark inj. 0.2mL once in this study.
Charcotrace Inj.	Active comparator	Drug: Charcotrace Inj.Charcotrace Inj. about 0.3~1mL

Who may qualify

Ages: 19 to 80 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (12 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
LuminoMark inj. 0.1mLAlso: LuminoMark inj.(Conc. for fluorescence) 0.1mLInjection LuminoMark inj. (Conc. for fluorescence) 0.1mL once in this study.	Drug	LuminoMark inj. 0.1mL
LuminoMark inj. 0.2mLAlso: LuminoMark inj.(Conc. for fluorescence) 0.2mLInjection LuminoMark inj. (Conc. for fluorescence) 0.2mL once in this study.	Drug	LuminoMark inj. 0.2mL
Charcotrace Inj.Also: Charcotrace Injection(Activated Charcoal 40mg/1ml)Injection Charcotrace Inj. about 0.3~1mL once in this study.	Drug	Charcotrace Inj.

Primary outcome

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.

4 secondary outcomes

Coloring confirmation rate of excision lesion.
Time frame: Visit 3(Day 0)
Technical success rate
Time frame: 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)
Pigmentation
Time frame: Visit 5(Day 10~Day 24)

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2019.
Derived from this study: PubMed 33726718Kim 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Seok Won Kim, PI principal investigator

Samsung Medical Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing LuminoMark inj. 0.1mL, LuminoMark inj. 0.2mL and Charcotrace Inj. in people with Breast Diseases, run by Hanlim Pharm. Co., Ltd. at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03743259, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2019.