Ignite Creation Date:
2025-12-24 @ 10:40 PM
Ignite Modification Date:
2025-12-30 @ 10:03 AM
Study NCT ID:
NCT04492735
Status:
UNKNOWN
Last Update Posted:
2020-07-30
First Post:
2020-07-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Use of Indocyanine Green as a Diagnostic Adjunct for Pediatric Solid Malignancies
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009362', 'term': 'Neoplasm Metastasis'}], 'ancestors': [{'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 45}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-06-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2025-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-07-27', 'studyFirstSubmitDate': '2020-07-27', 'studyFirstSubmitQcDate': '2020-07-27', 'lastUpdatePostDateStruct': {'date': '2020-07-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diagnostic accuracy using pathologic correlation as gold standard measure', 'timeFrame': '2 years'}, {'measure': 'Short and long term event free and overall survival', 'timeFrame': '2 years'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Metastatic Disease', 'Primary Tumor', 'Solid Malignancies']}, 'descriptionModule': {'briefSummary': 'Use of indocyanine green will augment the accuracy of identification and resection of both primary solid malignancies as well as their pulmonary metastases, where applicable We will conduct a prospective feasibility study of pediatric patients with solid malignancies with or without lung metastatases who present at the time of initial diagnosis or relapse. These patients will receive a targeted dye to aid in the resection of these metastases. We plan to assess ICG as it relates to:\n\n1. Diagnostic accuracy using pathologic correlation as gold standard measure\n2. Short and long term event free and overall survival', 'detailedDescription': 'Patients diagnosed with solid malignancies or metastatic lesions who require clinically indicated resection will be identified by their Oncologist. The oncologist will inform the subject/family about the study and ask if they may be interested in participating. If the subject/family demonstrates potential interest in the study, the Pediatric Surgery Research team will discuss the risks and benefits of pre-operative ICG administration with the patients and enrollment.\n\nStudy subjects: All patients diagnosed with solid malignancies as well as those with metastatic disease distant from the primary tumor will be potentially eligible for the study. Diagnosis will be made:\n\n1. In a multimodal fashion including physical exam, radiologic evaluation (ultrasound, MRI, CT scan, etc), and sometimes biopsy.\n2. Prior to definitive surgical resection of the newly diagnosed malignancy'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '45 Years', 'minimumAge': '1 Day', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Oncology solid, primary malignancies or their related metastatic lesion', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAll patients with newly diagnosed solid, primary malignancies or their related metastatic lesions.\n\nDiagnosis of primary or metastatic malignancy will be made by combination of:\n\n1. Clinical evaluation and physical exam\n2. Radiologic study including ultrasound, CT scan, and/or MRI\n3. Pathologic diagnosis after biopsy\n\nExclusion Criteria:\n\n1. Those patients and parents/guardians unwilling to provide consent/assent.\n2. Pregnant and/or women who are breast feeding.\n3. Patients with Iodine allergies'}, 'identificationModule': {'nctId': 'NCT04492735', 'briefTitle': 'The Use of Indocyanine Green as a Diagnostic Adjunct for Pediatric Solid Malignancies', 'organization': {'class': 'OTHER', 'fullName': "Children's Hospital Medical Center, Cincinnati"}, 'officialTitle': 'The Use of Indocyanine Green as a Diagnostic Adjunct for Pediatric Solid', 'orgStudyIdInfo': {'id': 'PSORC ICG'}}, 'contactsLocationsModule': {'locations': [{'zip': '45229', 'city': 'Cincinnati', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Erin Watters', 'role': 'CONTACT', 'email': 'erin.watters@cchmc.org', 'phone': '513-803-7024'}], 'facility': 'Cincinnati Childrens Hospital Medical Center', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}], 'centralContacts': [{'name': 'Erin Watters', 'role': 'CONTACT', 'email': 'erin.watters@cchmc.org', 'phone': '513-803-7024'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Roshni Dasgupta', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Roshni Dasgupta, MD', 'investigatorFullName': 'Roshni Dasgupta', 'investigatorAffiliation': "Children's Hospital Medical Center, Cincinnati"}}}}