Breast DiseasesPhase 3NCT04606329
To Evaluate the Efficacy and Safety of LuminoMark Injection in Patients With Nonpalpable Breast Lesions(Phase 3)
A Phase 3 study testing LuminoMark inj.(Conc. for fluorescence) and Charcotrace Inj. in people with Breast Diseases, run by Hanlim Pharm. Co., Ltd. at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- Breast Diseases
- What is being tested?
- LuminoMark inj.(Conc. for fluorescence) and Charcotrace Inj.
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 109 participants
- Where
- 1 siteSouth Korea
- Study dates
- 20 Jul 2020to 28 Jan 2021
- Phase
- Phase 3
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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
Show all 12Show fewer
- 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.
About this study
Official 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
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.
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.(Conc. for fluorescence), 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.(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.
| Study group | Role | What they receive |
|---|---|---|
| LuminoMark inj. | Experimental | Injection LuminoMark inj. 0.2mL once in this study. Receives: Drug: LuminoMark inj.(Conc. for fluorescence) |
| 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.
Negative Resection margin rate
The presence or absence of margin involvement in the resected breast lesions
Measured: Visit 5 (Day 14 ~Day 24)
Secondary outcomes (6)
Technical success rate
The proportion of colored lesion when make an incision
Measured: Visit 3 (Day 0)
Coloring confirmation rate of excision lesion
The proportion of colored excision lesion
Measured: Visit 3 (Day 0)
Pathologic perfection
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]
Measured: Visit 5 (Day 14 ~Day 24)
Pigmentation rate
Check whether skin is pigmented or not
Measured: Visit 5 (Day 14 ~Day 24)
Re-operation rate
The number of subjects who need re-operation is evaluated based on the investigator's comprehensive judgment including histopathology test results.
Measured: Visit 5 (Day 14 ~Day 24)
Procedure complication rate
Evaluate the numbers of subjects with procedure complication after lesion removal
Measured: Visit 4, 5 (Day 1, Day 14 ~Day 24)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2020
- Study start20 Jul 2020
- Primary completion28 Jan 2021
- Study completion28 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hanlim Pharm. Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04606329
- Sponsor's protocol ID
- HL_LMN_301
- Status last verified
- Feb 2021
- First submitted
- 14 Oct 2020
- Last updated
- 10 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT04606329
- Acronym / sponsor ID
- HL_LMN_301
- Conditions
- Breast Diseases
- Keywords
- Nonpalpable Breast Lesions
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- Hanlim Pharm. Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 20 Jul 2020 (actual)
- Primary completion
- 28 Jan 2021 (actual)
- Study completion
- 28 Jan 2021 (actual)
- First posted
- 28 Oct 2020 (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, Randomized, Open-label, Parallel, Phase 3 Clinical Trial in 8 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LuminoMark inj. | Experimental | Drug: LuminoMark inj.(Conc. for fluorescence)Injection 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
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
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.(Conc. for fluorescence)Injection LuminoMark inj. (Conc. for fluorescence) 0.2mL once in this study. | Drug | LuminoMark inj. |
| Charcotrace Inj.Injection Charcotrace Inj. about 0.3~1mL once in this study. | Drug | Charcotrace Inj. |
Primary outcome
Negative Resection margin rate
Time frame: Visit 5 (Day 14 ~Day 24)
The presence or absence of margin involvement in the resected breast lesions
6 secondary outcomes
Technical success rate
Time frame: Visit 3 (Day 0)
Coloring confirmation rate of excision lesion
Time frame: Visit 3 (Day 0)
Pathologic perfection
Time frame: Visit 5 (Day 14 ~Day 24)
Pigmentation rate
Time frame: Visit 5 (Day 14 ~Day 24)
Re-operation rate
Time frame: Visit 5 (Day 14 ~Day 24)
Procedure complication rate
Time frame: Visit 4, 5 (Day 1, Day 14 ~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 10 Feb 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing LuminoMark inj.(Conc. for fluorescence) 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 10 Feb 2021. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Negative Resection margin rate (time frame: Visit 5 (Day 14 ~Day 24)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Feb 2021.