Ignite Creation Date:
2025-12-24 @ 7:45 PM
Ignite Modification Date:
2026-02-23 @ 6:24 AM
Study NCT ID:
NCT04165603
Status:
UNKNOWN
Last Update Posted:
2019-11-18
First Post:
2019-11-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fluorescence-navigated Thoracoscopy for Detection of Small Pulmonary Nodules
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003074', 'term': 'Solitary Pulmonary Nodule'}, {'id': 'D055613', 'term': 'Multiple Pulmonary Nodules'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 352}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-12-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'completionDateStruct': {'date': '2021-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-11-13', 'studyFirstSubmitDate': '2019-11-10', 'studyFirstSubmitQcDate': '2019-11-13', 'lastUpdatePostDateStruct': {'date': '2019-11-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-11-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Signal-to-background Ratio (SBR) of the Tumor and Normal Parenchyma', 'timeFrame': 'within 1 week after surgery', 'description': 'We use image analysis software ImageJ to evaluate the strength of luminosity in tumors and normal parenchyma using intraoperative images and calculate signal-to-background-ratios.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pulmonary Nodule, Solitary', 'Pulmonary Nodule, Multiple']}, 'descriptionModule': {'briefSummary': 'Fluorescence-navigated thoracoscopic imaging with indocyanine green (ICG) is a novel technique for detection of small pulmonary nodules other than traditional radiography or intraoperative palpation. As a non-targeted fluorescent contrast agent, ICG accumulates in tumors by the enhanced permeability and retention effect (EPR), making the lesions fluoresce under fluorescent imaging. However, the optimal dosage and injection time of ICG are still under exploration. Hence, we perform this study in humans made up of four groups to determine the optimal time and dose.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Peripheral pulmonary solid nodules, with diameter 1-3 cm.\n* Suitable for surgery and signed informed consent.\n\nExclusion Criteria:\n\n* Liver dysfunction.\n* Allergic to indocyanine green.\n* Can't tolerate thoracoscopic surgery."}, 'identificationModule': {'nctId': 'NCT04165603', 'briefTitle': 'Fluorescence-navigated Thoracoscopy for Detection of Small Pulmonary Nodules', 'organization': {'class': 'OTHER', 'fullName': "Peking University People's Hospital"}, 'officialTitle': 'Fluorescence-navigated Thoracoscopy for Detection of Small Pulmonary Nodules', 'orgStudyIdInfo': {'id': '2018PHB144-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '5mg/kg of ICG, 24h before surgery', 'description': '5mg/kg of indocyanine green, intravenously injection 24 hours before surgery', 'interventionNames': ['Procedure: Preoperative Infusion of Indocyanine Green']}, {'type': 'EXPERIMENTAL', 'label': '1mg/kg of ICG, 24h before surgery', 'description': '1mg/kg of indocyanine green, intravenously injection 24 hours before surgery', 'interventionNames': ['Procedure: Preoperative Infusion of Indocyanine Green']}, {'type': 'EXPERIMENTAL', 'label': '5mg/kg of ICG, 48h before surgery', 'description': '5mg/kg of indocyanine green, intravenously injection 48 hours before surgery', 'interventionNames': ['Procedure: Preoperative Infusion of Indocyanine Green']}, {'type': 'EXPERIMENTAL', 'label': '1mg/kg of ICG, 48h before surgery', 'description': '1mg/kg of indocyanine green, intravenously injection 48 hours before surgery', 'interventionNames': ['Procedure: Preoperative Infusion of Indocyanine Green']}], 'interventions': [{'name': 'Preoperative Infusion of Indocyanine Green', 'type': 'PROCEDURE', 'description': 'preoperatively infuse indocyanine green through peripheral vein', 'armGroupLabels': ['1mg/kg of ICG, 24h before surgery', '1mg/kg of ICG, 48h before surgery', '5mg/kg of ICG, 24h before surgery', '5mg/kg of ICG, 48h before surgery']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100044', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Feng Yang, MD', 'role': 'CONTACT', 'email': 'yangfeng1007@sina.com', 'phone': '+8618612978269'}], 'facility': "Peking University People's Hospital", 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Feng Yang, MD', 'role': 'CONTACT', 'email': 'yangfeng1007@sina.com', 'phone': '(+86) 18612978269'}, {'name': 'Tiezheng Li, MD', 'role': 'CONTACT', 'email': 'tiezhengli@foxmail.com', 'phone': '(+86) 18811768786'}], 'overallOfficials': [{'name': 'Wang Jun, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': "Peking University People's Hospital"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Peking University People's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief，Thoracic Surgery Service', 'investigatorFullName': 'Jun Wang', 'investigatorAffiliation': "Peking University People's Hospital"}}}}