Ignite Creation Date:
2025-12-24 @ 5:40 PM
Ignite Modification Date:
2026-04-15 @ 12:11 PM
Study NCT ID:
NCT02851368
Status:
COMPLETED
Last Update Posted:
2017-11-21
First Post:
2016-07-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Near Infrared Fluorescence Imaging With Indocyanine Green
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003074', 'term': 'Solitary Pulmonary Nodule'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract 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': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-11', 'completionDateStruct': {'date': '2017-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-11-19', 'studyFirstSubmitDate': '2016-07-05', 'studyFirstSubmitQcDate': '2016-07-27', 'lastUpdatePostDateStruct': {'date': '2017-11-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-08-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visibility in situ, white light', 'timeFrame': 'Through study completion, an average of one year'}, {'measure': 'Visibility in situ, fluorescence', 'timeFrame': 'Through study completion, an average of one year'}, {'measure': 'Nodule malignancy', 'timeFrame': 'Through study completion, an average of one year'}], 'secondaryOutcomes': [{'measure': 'Visibility ex vivo, white light', 'timeFrame': 'Through study completion, an average of one year'}, {'measure': 'Visibility ex vivo, fluorescence', 'timeFrame': 'Through study completion, an average of one year'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Indocyanine Green', 'Fluorescence Imaging'], 'conditions': ['Solitary Pulmonary Nodules']}, 'descriptionModule': {'briefSummary': 'This research study will evaluate how Near Infrared Fluorescence imaging (NIFI) with indocyanine green (ICG) contrast dye can assist in the identification and diagnosis of lung nodules during surgery. NIFI is an intraoperative imaging technology that utilizes a coupled camera/fluorophore (ICG) system to fluoresce tissues of interest. Intravenous ICG is a fluorophore with a long-standing high safety profile.', 'detailedDescription': 'This research study is a pilot test of the effectiveness of a near infrared fluorescence imaging (NIFI) system in the detection and diagnosis of pulmonary nodules. Patients selected for enrollment in this study will be adults (≥18 years) that have been scheduled for surgical biopsy and/or resection of a primary lung nodule identified by prior imaging. Patients will receive an injection of indocyanine green (ICG) contrast dye one day prior to their surgery. Intraoperatively, the NIFI system will be used to visualize and characterize the fluorescence patterns given off by these lung nodules, as well as look for additional undiagnosed nodules. These nodules will then be resected and receive histological characterization, as per standard of care. The NIFI system will be evaluated for its ability to 1) visualize nodules and their margins 2) differentiate between benign and malignant nodules and 3) identify additional undiagnosed nodules.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects must be willing to undergo surgical biopsy and/or resection of pulmonary nodule(s).\n* Women and men at least 18 years of age\n* Subjects must have a CT scan of the chest within 8 weeks of surgery\n\nExclusion Criteria:\n\n* Previous thoracic surgery\n* Inoperable tumor/nodule\n* Unable to tolerate surgery\n* History of allergies to iodides\n* Breast feeding\n* Pregnant'}, 'identificationModule': {'nctId': 'NCT02851368', 'acronym': 'NIFI-ICG', 'briefTitle': 'Near Infrared Fluorescence Imaging With Indocyanine Green', 'organization': {'class': 'OTHER', 'fullName': 'University of Pittsburgh'}, 'officialTitle': 'A Pilot Trial of Near Infrared Fluorescence Imaging With Indocyanine Green in the Detection and Diagnosis of Neoplastic Pulmonary Nodules', 'orgStudyIdInfo': {'id': 'UPCI 15-205'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Near Infrared Fluorescence Imaging with Indocyanine Green', 'description': 'Patients will receive an injection of indocyanine green (ICG) 1 day prior to surgery. Near infrared fluorescence imaging (NIFI) will be used to identify pulmonary nodules during the surgical biopsy and/or resection procedure.', 'interventionNames': ['Device: near infrared fluorescence imaging (NIFI)', 'Drug: Indocyanine Green']}], 'interventions': [{'name': 'near infrared fluorescence imaging (NIFI)', 'type': 'DEVICE', 'description': 'The NIFI system will be evaluated for its ability to 1) visualize nodules and their margins 2) differentiate between benign and malignant nodules and 3) identify additional undiagnosed nodules after receiving an injection of indocyanine green 1 day prior to planned surgery.', 'armGroupLabels': ['Near Infrared Fluorescence Imaging with Indocyanine Green']}, {'name': 'Indocyanine Green', 'type': 'DRUG', 'description': 'Indocyanine Green will be administered intravenously 1 day prior to NIFI.', 'armGroupLabels': ['Near Infrared Fluorescence Imaging with Indocyanine Green']}]}, 'contactsLocationsModule': {'locations': [{'zip': '15232', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Department of Cardiothoracic Surgery', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}], 'overallOfficials': [{'name': 'Inderpal Sarkaria, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pittsburgh Medical Center/UPP'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pittsburgh', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Inderpal Sarkaria, MD', 'investigatorAffiliation': 'University of Pittsburgh'}}}}