Ignite Creation Date:
2025-12-24 @ 3:02 PM
Ignite Modification Date:
2026-03-03 @ 9:15 PM
Study NCT ID:
NCT03743259
Status:
COMPLETED
Last Update Posted:
2019-06-06
First Post:
2018-11-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
To Evaluate the Efficacy and Safety of LuminoMark Injection in Patients With Nonpalpable Breast Lesions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001941', 'term': 'Breast Diseases'}], 'ancestors': [{'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005453', 'term': 'Fluorescence'}], 'ancestors': [{'id': 'D049449', 'term': 'Luminescence'}, {'id': 'D008027', 'term': 'Light'}, {'id': 'D060733', 'term': 'Electromagnetic Radiation'}, {'id': 'D055590', 'term': 'Electromagnetic Phenomena'}, {'id': 'D060328', 'term': 'Magnetic Phenomena'}, {'id': 'D055585', 'term': 'Physical Phenomena'}, {'id': 'D055620', 'term': 'Optical Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 44}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-05-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2019-04-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-06-05', 'studyFirstSubmitDate': '2018-11-08', 'studyFirstSubmitQcDate': '2018-11-13', 'lastUpdatePostDateStruct': {'date': '2019-06-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-11-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-01-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'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])", 'timeFrame': 'Visit 3(Day 0)', 'description': "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."}], 'secondaryOutcomes': [{'measure': 'Coloring confirmation rate of excision lesion.', 'timeFrame': 'Visit 3(Day 0)', 'description': 'The proportion of colored excision lesion'}, {'measure': 'Technical success rate', 'timeFrame': 'Visit 3(Day 0)', 'description': 'The proportion of colored lesion when make an incision'}, {'measure': "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])", 'timeFrame': 'Visit 3(Day 0)', 'description': "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."}, {'measure': 'Pigmentation', 'timeFrame': 'Visit 5(Day 10~Day 24)', 'description': 'Check whether skin is pigmented or not'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Nonpalpable Breast Lesions'], 'conditions': ['Breast Diseases']}, 'referencesModule': {'references': [{'pmid': '33726718', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': 'This study is a multicenter, Open-label, Parallel, Phase 2 Clinical Trial in 6 weeks for screening, once Investigational product injection, Follow up visit.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '19 Years', 'genderBased': True, 'genderDescription': 'Only female', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Female, 19 years ≤ age ≥ 80 years\n2. Those who be expected to do operation about non palpable breast lesion excision\n3. Those who have lesion vial mammography and breast ultrasound\n4. Written consent voluntarily to participate in this clinical trial\n\nExclusion Criteria:\n\n1. Patients who be expected to do mastectomy\n2. Patients with multiple tumor or diffuse microcalcification\n3. Patients who have ink on invasive cancer or ductal carcinoma in situ despite 3 times local resection\n4. Patients who were treated with moderate to severe radiotherapy\n5. Patients who were treated with neoadjuvant Chemotherapy\n6. Patients with active invading skin connective tissue disease\n7. Patients with local progressing breast cancer or inflammatory local progressing breast cancer\n8. Patients who have an allergy to investigational product or any of the component with the Investigational product\n9. Patients who disagree about contraception for this clinical trial\n10. A pregnant women or lactating women\n11. Patients who participated in other clinical trials within the past 12 weeks from the date of informed consent\n12. Patients who investigators determines unsuitable for this clinical trial'}, 'identificationModule': {'nctId': 'NCT03743259', 'briefTitle': 'To Evaluate the Efficacy and Safety of LuminoMark Injection in Patients With Nonpalpable Breast Lesions', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hanlim Pharm. Co., Ltd.'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'HL_LMN_201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'LuminoMark inj. 0.1mL', 'description': 'Injection LuminoMark inj. 0.1mL once in this study.', 'interventionNames': ['Drug: LuminoMark inj. 0.1mL']}, {'type': 'EXPERIMENTAL', 'label': 'LuminoMark inj. 0.2mL', 'description': 'Injection LuminoMark inj. 0.2mL once in this study.', 'interventionNames': ['Drug: LuminoMark inj. 0.2mL']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Charcotrace Inj.', 'description': 'Charcotrace Inj. about 0.3\\~1mL', 'interventionNames': ['Drug: Charcotrace Inj.']}], 'interventions': [{'name': 'LuminoMark inj. 0.1mL', 'type': 'DRUG', 'otherNames': ['LuminoMark inj.(Conc. for fluorescence) 0.1mL'], 'description': 'Injection LuminoMark inj. (Conc. for fluorescence) 0.1mL once in this study.', 'armGroupLabels': ['LuminoMark inj. 0.1mL']}, {'name': 'LuminoMark inj. 0.2mL', 'type': 'DRUG', 'otherNames': ['LuminoMark inj.(Conc. for fluorescence) 0.2mL'], 'description': 'Injection LuminoMark inj. (Conc. for fluorescence) 0.2mL once in this study.', 'armGroupLabels': ['LuminoMark inj. 0.2mL']}, {'name': 'Charcotrace Inj.', 'type': 'DRUG', 'otherNames': ['Charcotrace Injection(Activated Charcoal 40mg/1ml)'], 'description': 'Injection Charcotrace Inj. about 0.3\\~1mL once in this study.', 'armGroupLabels': ['Charcotrace Inj.']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06351', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Samsung Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Seok Won Kim, PI', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Samsung Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hanlim Pharm. Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}