- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04606329
To Evaluate the Efficacy and Safety of LuminoMark Injection in Patients With Nonpalpable Breast Lesions(Phase 3)
February 9, 2021 updated by: Hanlim Pharm. Co., Ltd.
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.
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)
109
Phase
- Phase 3
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
-
-
-
Seoul, Korea, Republic of, 06351
- Samsung Medical Center
-
-
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
17 years to 78 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
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: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: LuminoMark inj.
Injection LuminoMark inj.
0.2mL once in this study.
|
Injection LuminoMark inj.
(Conc.
for fluorescence) 0.2mL once in this study.
|
Active Comparator: Charcotrace Inj.
Charcotrace Inj. about 0.3~1mL
|
Injection Charcotrace Inj. about 0.3~1mL once in this study.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Negative Resection margin rate
Time Frame: Visit 5 (Day 14 ~Day 24)
|
The presence or absence of margin involvement in the resected breast lesions
|
Visit 5 (Day 14 ~Day 24)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Technical success rate
Time Frame: Visit 3 (Day 0)
|
The proportion of colored lesion when make an incision
|
Visit 3 (Day 0)
|
Coloring confirmation rate of excision lesion
Time Frame: Visit 3 (Day 0)
|
The proportion of colored excision lesion
|
Visit 3 (Day 0)
|
Pathologic perfection
Time Frame: Visit 5 (Day 14 ~Day 24)
|
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]
|
Visit 5 (Day 14 ~Day 24)
|
Pigmentation rate
Time Frame: Visit 5 (Day 14 ~Day 24)
|
Check whether skin is pigmented or not
|
Visit 5 (Day 14 ~Day 24)
|
Re-operation rate
Time Frame: Visit 5 (Day 14 ~Day 24)
|
The number of subjects who need re-operation is evaluated based on the investigator's comprehensive judgment including histopathology test results.
|
Visit 5 (Day 14 ~Day 24)
|
Procedure complication rate
Time Frame: Visit 4, 5 (Day 1, Day 14 ~Day 24)
|
Evaluate the numbers of subjects with procedure complication after lesion removal
|
Visit 4, 5 (Day 1, Day 14 ~Day 24)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
July 20, 2020
Primary Completion (Actual)
January 28, 2021
Study Completion (Actual)
January 28, 2021
Study Registration Dates
First Submitted
October 14, 2020
First Submitted That Met QC Criteria
October 26, 2020
First Posted (Actual)
October 28, 2020
Study Record Updates
Last Update Posted (Actual)
February 10, 2021
Last Update Submitted That Met QC Criteria
February 9, 2021
Last Verified
February 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HL_LMN_301
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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