Ignite Creation Date:
2025-12-24 @ 9:20 PM
Ignite Modification Date:
2025-12-24 @ 9:20 PM
Study NCT ID:
NCT05365204
Status:
UNKNOWN
Last Update Posted:
2022-05-09
First Post:
2022-04-27
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study for Optimization of 6% Hydroxyethyl Starch Based Indocyanine Green Near-infrared Fluorescence Navigated Sentinel Lymph Node Biopsy for Breast Cancer Patients
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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'The participant will know how many concentration ladders we have, but will not know the exact concentration used on him.'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The participants will be assigned to sentinel lymph node biopsies using different concentrations of voluven based indocyanine green. Estimated concentration grouping (ICG mg / Voluven mL): 2.5, 0.5, 0.25, 0.125, 0.0625. Planned recruiting at least 3 participants in each diluted concentration group. The dilution rate will advance if imaging quality is improving compared with the last concentration group. The study will be completed if the best imaging quality injection protocol is found.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 24}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-04-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2023-04-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-05-06', 'studyFirstSubmitDate': '2022-04-27', 'studyFirstSubmitQcDate': '2022-05-06', 'lastUpdatePostDateStruct': {'date': '2022-05-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-04-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Signal-to-background ratio (SBR)', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Evaluates the SBR of the near-infrared fluorescence between the retrieved sentinel lymph nodes and the background.'}, {'measure': 'Penetration depth', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Evaluates the depth of the deepest visualized subcutaneous lymphatics in the breast'}], 'secondaryOutcomes': [{'measure': 'Sentinel lymph nodes pathology', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'The positivity and number of retrieved sentinel lymph nodes at definitive pathology report.'}, {'measure': 'Time to total visualization of breast subcutaneous lymphatics', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'The time from injection of indocyanine green to total visualization of breast subcutaneous lymphatics'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Indocyanine green', 'Sentinel lymph node biopsy', 'Axillary lymph node dissection'], 'conditions': ['Breast Cancer', 'Sentinel Lymph Node']}, 'referencesModule': {'references': [{'pmid': '21360250', 'type': 'BACKGROUND', 'citation': 'Mieog JS, Troyan SL, Hutteman M, Donohoe KJ, van der Vorst JR, Stockdale A, Liefers GJ, Choi HS, Gibbs-Strauss SL, Putter H, Gioux S, Kuppen PJ, Ashitate Y, Lowik CW, Smit VT, Oketokoun R, Ngo LH, van de Velde CJ, Frangioni JV, Vahrmeijer AL. Toward optimization of imaging system and lymphatic tracer for near-infrared fluorescent sentinel lymph node mapping in breast cancer. Ann Surg Oncol. 2011 Sep;18(9):2483-91. doi: 10.1245/s10434-011-1566-x. Epub 2011 Mar 1.'}]}, 'descriptionModule': {'briefSummary': 'A study for dosage-image optimization of 6% hydroxyethyl starch diluted indocyanine green for near-infrared fluorescence navigated sentinel lymph node mapping for breast cancer patient.', 'detailedDescription': 'Pre-clinical experiment has shown using 6% hydroxyethyl starch (Voluven®) as a solvent, compared with pure water, can improve brightness of indocyanine green particles at the same concentration. Similar findings have been addressed using human serum albumin as a solvent for indocyanine green in previous studies, but there was no report using 6% hydroxyethyl starch as a solvent till now. This study aims for clinical translation and optimization of 6% hydroxyethyl starch diluted indocyanine green in breast cancer patients undergoing sentinel lymph node biopsy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Breast cancer, adults\n\nExclusion Criteria:\n\n* Patient aged \\< 20 years old\n* Primary lesion without indication of sentinel lymph node biopsy in current guidelines (Low-risk ductal carcinoma in situ or metastatic breast cancer)\n* Patient who is allergic to primary tracers (including Tc99m and blue dye)\n* Patient who is allergic to indocyanine green'}, 'identificationModule': {'nctId': 'NCT05365204', 'briefTitle': 'A Study for Optimization of 6% Hydroxyethyl Starch Based Indocyanine Green Near-infrared Fluorescence Navigated Sentinel Lymph Node Biopsy for Breast Cancer Patients', 'organization': {'class': 'OTHER', 'fullName': 'National Taiwan University Hospital Hsin-Chu Branch'}, 'officialTitle': 'A Study for Optimization of 6% Hydroxyethyl Starch Based Indocyanine Green Near-infrared Fluorescence Navigated Sentinel Lymph Node Biopsy for Breast Cancer Patients', 'orgStudyIdInfo': {'id': '111-009-F'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Voluven diluted indocyanine green', 'description': 'This arm participants uses Voluven diluted ICG for sentinel lymph node mapping.', 'interventionNames': ['Procedure: Near infrared fluorescence navigated sentinel lymph node mapping']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Distilled-water diluted indocyanine green', 'description': 'This arm participants uses Distilled-water diluted ICG for sentinel lymph node mapping.', 'interventionNames': ['Procedure: Near infrared fluorescence navigated sentinel lymph node mapping']}], 'interventions': [{'name': 'Near infrared fluorescence navigated sentinel lymph node mapping', 'type': 'PROCEDURE', 'description': 'Patient will undergo sentinel lymph node biopsy with near infrared fluorescence navigation. The dosage of ICG will not exceed 2.5 mg in total, and the volume of the assigned solvent will not exceed 5 mL in total.', 'armGroupLabels': ['Distilled-water diluted indocyanine green', 'Voluven diluted indocyanine green']}]}, 'contactsLocationsModule': {'locations': [{'zip': '302', 'city': 'Zhubei', 'state': 'HsinChu County', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Yung-Chun Hsieh, MD', 'role': 'CONTACT', 'email': 'abitzsong@gmail.com', 'phone': '+886-972322925'}], 'facility': 'National Taiwan University Hospital Hsin-Chu Branch Biomedical Park Hospital', 'geoPoint': {'lat': 24.83833, 'lon': 121.00778}}], 'centralContacts': [{'name': 'Yung-Chun Hsieh, MD', 'role': 'CONTACT', 'email': 'abitzsong@gmail.com', 'phone': '+886-972322925'}, {'name': 'Yang-Hsiang Chan, PhD', 'role': 'CONTACT', 'email': 'yhchan@nycu.edu.tw', 'phone': '+886-966626689'}], 'overallOfficials': [{'name': 'Yung-Chun Hsieh, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'National Taiwan University Hospital Hsin-Chu Branch'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Taiwan University Hospital Hsin-Chu Branch', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Yang Ming Chiao Tung University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}