Ignite Creation Date:
2025-12-25 @ 4:14 AM
Ignite Modification Date:
2025-12-26 @ 3:13 AM
Study NCT ID:
NCT03458520
Status:
RECRUITING
Last Update Posted:
2025-11-18
First Post:
2018-03-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pediatric PET/MR Image Registry
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D012516', 'term': 'Osteosarcoma'}], 'ancestors': [{'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D018213', 'term': 'Neoplasms, Bone Tissue'}, {'id': 'D009372', 'term': 'Neoplasms, Connective Tissue'}, {'id': 'D018204', 'term': 'Neoplasms, Connective and Soft Tissue'}, {'id': 'D012509', 'term': 'Sarcoma'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D049268', 'term': 'Positron-Emission Tomography'}, {'id': 'D008279', 'term': 'Magnetic Resonance Imaging'}, {'id': 'D014057', 'term': 'Tomography, X-Ray Computed'}], 'ancestors': [{'id': 'D014055', 'term': 'Tomography, Emission-Computed'}, {'id': 'D007090', 'term': 'Image Interpretation, Computer-Assisted'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D007089', 'term': 'Image Enhancement'}, {'id': 'D010781', 'term': 'Photography'}, {'id': 'D011877', 'term': 'Radionuclide Imaging'}, {'id': 'D014054', 'term': 'Tomography'}, {'id': 'D003947', 'term': 'Diagnostic Techniques, Radioisotope'}, {'id': 'D011856', 'term': 'Radiographic Image Enhancement'}, {'id': 'D011859', 'term': 'Radiography'}, {'id': 'D014056', 'term': 'Tomography, X-Ray'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-17', 'studyFirstSubmitDate': '2018-03-02', 'studyFirstSubmitQcDate': '2018-03-02', 'lastUpdatePostDateStruct': {'date': '2025-11-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2018-03-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of tumors', 'timeFrame': 'up to 12 months', 'description': 'Number of tumors detected on whole body MRI, PET/MR and (if available) PET/CT scans.'}], 'secondaryOutcomes': [{'measure': 'Metabolic activity of tumors', 'timeFrame': 'up to 12 months', 'description': 'Metabolic activity of tumors determined by Standardized Uptake Values (SUV) on PET/MR and (if available) PET/CT scans.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Soft Tissue', 'Lymphoma', 'Osteosarcoma']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare whole body magnetic resonance (MR) imaging, whole body positron emission tomography (PET)/MR imaging, and (if available) PET/Computed Tomography (CT) imaging for the diagnosis of tumors in children and young adults. Sensitivities, specificities and diagnostic accuracies of the different imaging modalities will be compared for significant differences.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '40 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Pediatric and young adult (\\<40 years) male or female subjects with proven solid tumors or newly diagnosed mass strongly suspected to represent a solid tumor', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients with proven solid tumors or newly diagnosed mass strongly suspected to represent a solid tumor.\n* We might also include some patients with leukemia if there is concern for a focal lesion in any of their organs.\n* Participant's parents (if participant is under 18) or the participant (if participant is 18 years or older) must willingly give written informed consent prior to any image transfer to the image registry.\n\nExclusion Criteria:\n\n* Patient has contraindications for MRI or PET/MR. This includes patients with cardiac pacemakers or intracranial vascular clips as well as patients with a blood glucose level \\> 200 mg/dl.\n* Lack of parental permission (if participant is younger than 18) or lack of informed consent (if participant is at least 18 years of age).\n* Patient has a CNS primary tumor.\n* Pregnant women and fetuses"}, 'identificationModule': {'nctId': 'NCT03458520', 'briefTitle': 'Pediatric PET/MR Image Registry', 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'officialTitle': 'Pediatric PET/MR Image Registry', 'orgStudyIdInfo': {'id': 'IRB-44706'}, 'secondaryIdInfos': [{'id': 'PEDSVAR0049', 'type': 'OTHER', 'domain': 'OnCore'}, {'id': '5U24CA264298-04', 'link': 'https://reporter.nih.gov/quickSearch/5U24CA264298-04', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Image Registry', 'description': 'patients with proven solid tumors or newly diagnosed mass strongly suspected to represent a solid tumor will receive MR imaging, PET/MR imaging (and if available, PET/CT imaging)', 'interventionNames': ['Diagnostic Test: PET/MR imaging', 'Diagnostic Test: MR imaging', 'Diagnostic Test: PET/CT imaging']}], 'interventions': [{'name': 'PET/MR imaging', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['positron emission tomography'], 'description': 'undergo PET/MR imaging', 'armGroupLabels': ['Image Registry']}, {'name': 'MR imaging', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['magnetic resonance imaging'], 'description': 'Undergo MR imaging', 'armGroupLabels': ['Image Registry']}, {'name': 'PET/CT imaging', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['computed tomography'], 'description': 'Undergo PET/CT imaging', 'armGroupLabels': ['Image Registry']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94304', 'city': 'Palo Alto', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Anne Muehe', 'role': 'CONTACT', 'email': 'amuehe@stanford.edu', 'phone': '650-720-8601'}, {'name': 'Heike Daldrup-Link, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Stanford University, School of Medicine', 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}], 'centralContacts': [{'name': 'Anne Muehe', 'role': 'CONTACT', 'email': 'amuehe@stanford.edu', 'phone': '650-720-8601'}], 'overallOfficials': [{'name': 'Heike Daldrup-Link, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stanford University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stanford University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}