Ignite Creation Date:
2025-12-25 @ 2:26 AM
Ignite Modification Date:
2026-01-07 @ 10:23 AM
Study NCT ID:
NCT02817334
Status:
UNKNOWN
Last Update Posted:
2016-06-29
First Post:
2016-06-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Prospective Clinical Study for Evaluation of Safe Resection Margin in Breast Conserving Surgery in Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007208', 'term': 'Indocyanine Green'}], 'ancestors': [{'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 149}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-06', 'completionDateStruct': {'date': '2016-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-06-26', 'studyFirstSubmitDate': '2016-06-01', 'studyFirstSubmitQcDate': '2016-06-26', 'lastUpdatePostDateStruct': {'date': '2016-06-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-06-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Side effects and availability Side effects and availability Side effects and availability side effects and availability', 'timeFrame': 'following up a week to 3 month', 'description': 'Itchiness, erythema, rash and other allergic reactions there could have shots later.\n\nItchiness, erythema, rash and other allergic reactions there could have shots later.\n\nItchiness, erythema, rash and other allergic reactions there could have shots later.\n\nItchiness, erythema, rash and other allergic reactions there could have shots later.'}, {'measure': 'side effects and availability', 'timeFrame': 'following up a week to 3 month', 'description': 'After scanning, difficulty breathing, a decrease in blood pressure checked whether he had o reaction, such as anaphylactic shock.'}, {'measure': 'side effects ans availability', 'timeFrame': 'following up a week to 3 month', 'description': "The skin discoloration, verify that there aren't stay in a follow-up after three months after surgery."}], 'primaryOutcomes': [{'measure': 'detection rate', 'timeFrame': 'one day', 'description': 'after complete resection with intraoperative ultrasound confirmed the lesion'}], 'secondaryOutcomes': [{'measure': 'determine the pathological stability', 'timeFrame': 'one day', 'description': 'determine the pathological stability with biopsy results confirmed during surgery'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Near-infrared fluorescence', 'Indocyanine green, ICG', 'breast cancer'], 'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'Near-infrared (NIR) fluorescence imaging using indocyanine green (ICG) has been used for breast cancer surgery such as sentinel lymph node (SLN) mapping and breast cancer localization.\n\nIn this study, our hypothesis are as following:\n\n1. As inject only indocyanine green (ICG), it provide the surgeon visual guidance to ensure better outcome.\n2. indocyanine green (ICG) permitted accurate preoperative and intraoperative detection of the SLNs as well as nonpalpable benign brest lesion in patients with breast cancer.', 'detailedDescription': 'Indocyanine green, ICG (ICG-fluorescence)\n\n* ICG is the most commonly used fluorophore which approve by FDA.\n* NIR-F imaging with ICG could be used in various surgeries. For example, SLN mapping in breast cancer and localization of liver metastasis, especially superficial lesion\n* Contains sodium iodide, patients who have history of allergy to iodides should be used as caution.\n\nNonpalpable benign brest lesion localization\n\n* New method for the localization and resection of non-palpable breast lesions.\n* The breast lesion was correctly localized, and the area of ICG corresponded well to the site of the lesions.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* nonpalpable breast tumor \\< 5cm in patients with breast cancer.\n* consented patients with more than 18 years\n* Eastern Cooperative Oncology Group Performance status 0 or 1\n* patients who need breast biopsy as treatment for breast cancer.\n\nExclusion Criteria:\n\n* nonpalpable breast tumor ≥ 5cm in patients with breast cancer.\n* inflammatory cancer of breast or patients who need MRM\n* pregnancy\n* history of severe allergy to ICG(Indocyanine Green)\n* iode hypersensitiveness'}, 'identificationModule': {'nctId': 'NCT02817334', 'briefTitle': 'A Prospective Clinical Study for Evaluation of Safe Resection Margin in Breast Conserving Surgery in Breast Cancer', 'organization': {'class': 'OTHER_GOV', 'fullName': 'National Cancer Center, Korea'}, 'officialTitle': 'A Prospective Clinical Study for Evaluation of Safe Resection Margin in Breast Conserving Surgery', 'orgStudyIdInfo': {'id': 'NCC-1410202-3'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'indocyanine green', 'description': 'As inject only indocyanine green (ICG), it provide the surgeon visual guidance to ensure better outcome.\n\nIntervention: Drug: indocyanine green', 'interventionNames': ['Drug: indocyanine green']}], 'interventions': [{'name': 'indocyanine green', 'type': 'DRUG', 'otherNames': ['Near-infrared fluorescence'], 'description': 'As inject only indocyanine green (ICG), it provide the surgeon visual guidance to ensure better outcome.', 'armGroupLabels': ['indocyanine green']}]}, 'contactsLocationsModule': {'locations': [{'zip': '410-769', 'city': 'Goyang-si', 'state': 'Gyeonggi-do', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'So-Youn Jung', 'role': 'CONTACT', 'email': 'goje1@ncc.re.kr', 'phone': '+82-31-920-1681'}, {'name': 'So-Youn Jung', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'National Cancer Center', 'geoPoint': {'lat': 37.65639, 'lon': 126.835}}], 'centralContacts': [{'name': 'So-Youn Jung', 'role': 'CONTACT', 'email': 'goje1@ncc.re.kr', 'phone': '+82-31-920-1681'}], 'overallOfficials': [{'name': 'So-Youn Jung', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Cancer Center, Korea'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Cancer Center, Korea', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical Doctor', 'investigatorFullName': 'So-Youn Jung', 'investigatorAffiliation': 'National Cancer Center, Korea'}}}}