Ignite Creation Date:
2025-12-24 @ 3:32 PM
Ignite Modification Date:
2025-12-27 @ 10:00 AM
Study NCT ID:
NCT05199792
Status:
COMPLETED
Last Update Posted:
2022-01-20
First Post:
2021-12-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Gadoterate Meglumine in Diagnosis of Vascular Diseases Using MRA MRA
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014652', 'term': 'Vascular Diseases'}], 'ancestors': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 65}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-06-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2020-01-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-01-19', 'studyFirstSubmitDate': '2021-12-08', 'studyFirstSubmitQcDate': '2022-01-19', 'lastUpdatePostDateStruct': {'date': '2022-01-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assessment of MRA image quality', 'timeFrame': '18 months', 'description': 'assess the image quality of MRA studies acquired using these two contrast'}], 'secondaryOutcomes': [{'measure': 'Assessment of MRA accuracy', 'timeFrame': '18 months', 'description': 'Assess the accuracy of MRA studies acquired using these two contrast'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Vascular Diseases']}, 'referencesModule': {'references': [{'pmid': '12732691', 'type': 'BACKGROUND', 'citation': 'Eng J. Sample size estimation: how many individuals should be studied? Radiology. 2003 May;227(2):309-13. doi: 10.1148/radiol.2272012051.'}, {'pmid': '19116027', 'type': 'RESULT', 'citation': 'Seeger A, Kramer U, Fenchel M, Grimm F, Bretschneider C, Doring J, Klumpp B, Tepe G, Rittig K, Seidensticker PR, Claussen CD, Miller S. Comparison between a linear versus a macrocyclic contrast agent for whole body MR angiography in a clinical routine setting. J Cardiovasc Magn Reson. 2008 Dec 30;10(1):63. doi: 10.1186/1532-429X-10-63.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare magnetic resonance angiography (MRA) using gadoterate meglumine to clinically obtained MRA using gadobutrol. The specific aims are to show:\n\n1. Carotid, chest, and abdomenal MRA with gadoterate meglumine has a comparable image quality and diagnostic confidence to MRA using gadobutrol.\n2. Carotid, chest, and abdomenal MRA with gadoterate meglumine has a comparable accuracy for vascular lesion and stenosis detection compared to MRA using gadobutrol.', 'detailedDescription': 'In this study, we will assess the image quality and accuracy of MRA studies acquired using these two contrast agents. In the cases where Digital Subtraction Angiography (DSA) or CT angiography images are available, the results of the study using both contrast agents will be compared to the DSA or CTA findings. All MRA images will be assessed independently by two readers. The readers will be blinded to the clinical symptoms, contrast agent and DSA/CTA results. A five-level system rating for image quality of each arterial segment will be used (1 = non-diagnostic images, 2 = poor image quality, significant blurring/artefacts, diagnosis suspected but not established, 3 = fair quality with established diagnosis, 4=good quality with definite diagnosis, minimal blurring/artefacts, 5 = sharply defined borders, excellent quality image information). Vascular lesions will also be graded on a 1-5 scale. Vessel segment stenoses will be graded using a five-point grading scale as follows: (1) normal; (2) mild (\\<50% diameter stenosis); (3) moderate (50% to 74%), severe (75% to 99%); and (5) total occlusion.\n\nGrades 1 and 2 will be considered insignificant, while grades 3 to 5 will be interpreted as significant for diagnostic accuracy testing.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '89 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'qualifying MRA', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female subjects 18-89 years of age\n* Suspected or diagnosed vascular disease\n* Standard of care carotid, chest, or\n* Willingness to undergo 1 research MRA with up to double dose gadoterate meglumine\n* Able to complete the MR safety questionnaire\n* Able to comprehend and provide informed consent in English\n\nExclusion Criteria:\n\n* • Allergy to gadolinium-containing contrast media\n\n * Chronic, severe kidney disease\n * eGFR \\< 60mL/min/1.73m2\n * Acute kidney injury\n * Kidney or liver transplant within 8 weeks\n * Contraindication to MRI (implanted device, claustrophobia, dyspnea precluding the ability to follow breath-hold instructions)\n * Pregnant or breastfeeding women\n * Adults unable to consent\n * Individual who are not yet adults\n * Prisoners'}, 'identificationModule': {'nctId': 'NCT05199792', 'briefTitle': 'Efficacy of Gadoterate Meglumine in Diagnosis of Vascular Diseases Using MRA MRA', 'organization': {'class': 'OTHER', 'fullName': 'Northwestern University'}, 'officialTitle': 'Efficacy of Gadoterate Meglumine in Diagnosis of Vascular Diseases Using MRA', 'orgStudyIdInfo': {'id': 'STU00205041'}}, 'armsInterventionsModule': {'armGroups': [{'label': '2x dose of Dotarem', 'description': 'qualifying MRA', 'interventionNames': ['Diagnostic Test: Dotarem']}], 'interventions': [{'name': 'Dotarem', 'type': 'DIAGNOSTIC_TEST', 'description': '(Dotarem) (0.4 ml/kg (0.2 mmol/kg))', 'armGroupLabels': ['2x dose of Dotarem']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Yasmeen Khan', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'overallOfficials': [{'name': 'James Carr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Northwestern University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Northwestern University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'James Carr', 'investigatorAffiliation': 'Northwestern University'}}}}