Ignite Creation Date:
2025-12-24 @ 7:45 PM
Ignite Modification Date:
2026-03-27 @ 1:52 AM
Study NCT ID:
NCT03091803
Status:
WITHDRAWN
Last Update Posted:
2021-04-05
First Post:
2017-03-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
QSM and Regional DCE MRI Permeability Using GOCART Technique
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001932', 'term': 'Brain Neoplasms'}], 'ancestors': [{'id': 'D016543', 'term': 'Central Nervous System Neoplasms'}, {'id': 'D009423', 'term': 'Nervous System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000098543', 'term': 'Dynamic Contrast Enhanced Magnetic Resonance Imaging'}, {'id': 'C064572', 'term': 'gadobenic acid'}, {'id': 'C072417', 'term': 'gadoterate meglumine'}, {'id': 'C050823', 'term': "gadolinium 1,4,7,10-tetraazacyclododecane-N,N',N'',N'''-tetraacetate"}, {'id': 'D008279', 'term': 'Magnetic Resonance Imaging'}], 'ancestors': [{'id': 'D014054', 'term': 'Tomography'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'No accrual', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2017-04-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2021-04-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-04-01', 'studyFirstSubmitDate': '2017-03-21', 'studyFirstSubmitQcDate': '2017-03-21', 'lastUpdatePostDateStruct': {'date': '2021-04-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-03-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-04-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in QSM score', 'timeFrame': 'Baseline up to 18 months', 'description': 'Descriptive statistics will be used to describe the magnitude of Gd deposition measured by QSM score in each of the two study groups. Histograms will be generated for QSM score at each time point as well as the change from the baseline for each group. The descriptive statistics will be used to calculate the mean, median, interquartile range, and standard deviation. Box plot and overlying histogram will be used to illustrate the distribution of change in Gd deposition between gadobenate dimeglumine and gadoterate meglumine group. Correlation between QSM score versus (vs.) kTrans and QSM score v'}], 'secondaryOutcomes': [{'measure': 'Change in T1WI signal intensity ratio', 'timeFrame': 'Baseline up to 18 months', 'description': 'Descriptive statistics will be used to describe the magnitude of Gd deposition measured by T1WI signal intensity ratio in each of the two study groups. Histograms will be generated for T1WI signal intensity ratio score at each time point as well as the change from the baseline for each group. The descriptive statistics will be used to calculate the mean, median, interquartile range, and standard deviation. Box plot and overlying histogram will be used to illustrate the distribution of change in Gd deposition between gadobenate dimeglumine and gadoterate meglumine group. Correlation between T1W'}, {'measure': 'kTrans and Ve signal using GOCART 3D MRI', 'timeFrame': 'Up to 18 months', 'description': 'The signal (kTrans and Ve) will be obtained in voxel level then taking average within the region of interest (ROI). ROI will be placed on the pons, bilateral globi pallidi, thalami and dentate nuclei to obtain the average signal within the ROI. Averages of all bilateral measurements will be used to calculate the final signal for kTrans and Ve. The final kTrans and Ve signal will only be used to assess the correlation with QSM and T1WI signal intensity ratios.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Intracranial Neoplasm']}, 'descriptionModule': {'briefSummary': 'This randomized pilot clinical trial studies quantitative susceptibility mapping (QSM) and regional dynamic contrast enhanced (DCE) magnetic resonance imaging (MRI) permeability using golden-angle cartesian randomized time-resolved (GOCART) technique in evaluating regional gadolinium retention in the brain in patients with intracranial neoplasm receiving gadobenate dimeglumine or gadoterate meglumine. MRI diagnostic techniques such as, QSM and DCE MRI, may help to gather information regarding brain changes associated with gadolinium deposits during 8 to 18 months after administration of gadobenate dimeglumine or gadoterate meglumine.', 'detailedDescription': 'PRIMARY OBJECTIVES:\n\nI. To obtain preliminary data (e.g. mean, variance, distribution) in the regional brain parenchymal changes associated with gadolinium (Gd) deposition during 8 to 18 months period after administration of gadolinium based contrast agents (GBCA) to Gd naive intracranial neoplasm patients who will be randomized to gadobenate dimeglumine (MultiHance) or gadoterate meglumine (Dotarem).\n\nII. To explore if areas of increased regional Gd deposition at individual level are correlated with baseline regional DCE permeability metrics such as volume transfer coefficient reflecting vascular permeability (kTrans), extracellular volume ratio reflecting vascular permeability (ve) and plasma volume (vp) in intracranial neoplasm patients.\n\nOUTLINE: Patients are randomized to 1 of 2 arms.\n\nARM I: Patients undergo standard of care QSM and T1 weighted imaging (T1WI). Patients then receive gadobenate dimeglumine intravenously (IV) and undergo GOCART DCE MRI over 60 minutes.\n\nARM II: Patients undergo standard of care QSM and T1WI. Patients then receive gadoterate meglumine IV and undergo GOCART DCE MRI over 60 minutes.\n\nAfter completion of study, patients are followed up at 8-18 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients seen at USC/Norris Comprehensive Cancer Center who are found to have suspected intracranial neoplasm scheduled for routine MRI with GBCA (gadolinium naive patients) will be recruited for the study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient with suspected intracranial neoplasm scheduled for routine MRI with GBCA (gadolinium naive patients)\n* Willingness to comply with the study protocol\n\nExclusion Criteria:\n\n* Contraindications for MRI or GBCA (standard of care)\n* Abnormal renal function with estimated glomerular filtration rate (eGFR) less than 30 mL/min/m\\^2 based on creatinine obtained within last 30 days\n* History of previous administration of GBCA'}, 'identificationModule': {'nctId': 'NCT03091803', 'briefTitle': 'QSM and Regional DCE MRI Permeability Using GOCART Technique', 'organization': {'class': 'OTHER', 'fullName': 'University of Southern California'}, 'officialTitle': 'Evaluation of Regional Gadolinium Retention in the Brain Using QSM With Correlation to Regional DCE MRI Permeability Using GOCART Technique in Intracranial Neoplasm Patients Receiving Gadobenate Dimeglumine (MultiHance) or Gadoterate Meglumine (Dotarem)', 'orgStudyIdInfo': {'id': '6B-16-1'}, 'secondaryIdInfos': [{'id': 'NCI-2017-00499', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': '6B-16-1', 'type': 'OTHER', 'domain': 'USC / Norris Comprehensive Cancer Center'}, {'id': 'P30CA014089', 'link': 'https://reporter.nih.gov/quickSearch/P30CA014089', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Arm I (QSM, T1WI, gadobenate dimeglumine, GOCART DCE MRI)', 'description': 'Patients undergo standard of care QSM and T1WI. Patients then receive gadobenate dimeglumine IV and undergo GOCART DCE MRI over 60 minutes.', 'interventionNames': ['Device: Dynamic Contrast-Enhanced Magnetic Resonance Imaging', 'Drug: Gadobenate Dimeglumine', 'Device: Magnetic Resonance Imaging']}, {'label': 'Arm II (QSM, T1WI, gadoterate meglumine, GOCART DCE MRI)', 'description': 'Patients undergo standard of care QSM and T1WI. Patients then receive gadoterate meglumine IV and undergo GOCART DCE MRI over 60 minutes.', 'interventionNames': ['Device: Dynamic Contrast-Enhanced Magnetic Resonance Imaging', 'Drug: Gadoterate Meglumine', 'Device: Magnetic Resonance Imaging']}], 'interventions': [{'name': 'Dynamic Contrast-Enhanced Magnetic Resonance Imaging', 'type': 'DEVICE', 'otherNames': ['DCE MRI', 'DCE-MRI', 'DYNAMIC CONTRAST ENHANCED MRI'], 'description': 'Undergo GOCART DCE MRI', 'armGroupLabels': ['Arm I (QSM, T1WI, gadobenate dimeglumine, GOCART DCE MRI)', 'Arm II (QSM, T1WI, gadoterate meglumine, GOCART DCE MRI)']}, {'name': 'Gadobenate Dimeglumine', 'type': 'DRUG', 'otherNames': ['Gd-BOPTA', 'MultiHance'], 'description': 'Given IV', 'armGroupLabels': ['Arm I (QSM, T1WI, gadobenate dimeglumine, GOCART DCE MRI)']}, {'name': 'Gadoterate Meglumine', 'type': 'DRUG', 'otherNames': ['DOTAREM', 'Gd-DOTA'], 'description': 'Given IV', 'armGroupLabels': ['Arm II (QSM, T1WI, gadoterate meglumine, GOCART DCE MRI)']}, {'name': 'Magnetic Resonance Imaging', 'type': 'DEVICE', 'otherNames': ['Magnetic Resonance Imaging Scan', 'Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance', 'MRI', 'MRI Scan', 'NMR Imaging', 'NMRI', 'Nuclear Magnetic Resonance Imaging'], 'description': 'Undergo QSM and T1WI imaging', 'armGroupLabels': ['Arm I (QSM, T1WI, gadobenate dimeglumine, GOCART DCE MRI)', 'Arm II (QSM, T1WI, gadoterate meglumine, GOCART DCE MRI)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90033', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'USC / Norris Comprehensive Cancer Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}], 'overallOfficials': [{'name': 'Alexander Lerner', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Southern California'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Southern California', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}