Ignite Creation Date:
2025-12-24 @ 11:04 PM
Ignite Modification Date:
2026-01-04 @ 7:46 PM
Study NCT ID:
NCT02017769
Status:
COMPLETED
Last Update Posted:
2016-10-26
First Post:
2013-12-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
MRI in Diagnosing and Monitoring CIDP
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020277', 'term': 'Polyradiculoneuropathy, Chronic Inflammatory Demyelinating'}], 'ancestors': [{'id': 'D011129', 'term': 'Polyradiculoneuropathy'}, {'id': 'D020274', 'term': 'Autoimmune Diseases of the Nervous System'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D003711', 'term': 'Demyelinating Diseases'}, {'id': 'D011115', 'term': 'Polyneuropathies'}, {'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 39}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'completionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-10-25', 'studyFirstSubmitDate': '2013-12-06', 'studyFirstSubmitQcDate': '2013-12-16', 'lastUpdatePostDateStruct': {'date': '2016-10-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-12-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'DTI changes in nerves and muscles', 'timeFrame': 'At enrolment', 'description': 'Diffusion Tension Imaging (DTI) in peripheral nerves and muscles in the lower extremities in CIDP patients treated with SCIG will be compared to healthy controls'}], 'secondaryOutcomes': [{'measure': 'Changes in MRI findings between treated and untreated CIDP patients', 'timeFrame': 'All patients are examined at enrolment. Untreated patients are re-examined after 4 months of treatment', 'description': 'Comparing changes in MTR and DTI between CIDP patients treated with subcutaneous immunoglobulin to those untreated.\n\nThe untreated patients will be examined again after 4 months of treatment with immunoglobulin'}, {'measure': 'Comparing clinical findings to MRI', 'timeFrame': 'At enrolment', 'description': 'Clinical evaluation by:\n\nIsokinetic dynamometry Clinical MRC score\n\nThese findings wil be compared to findings on MRI to assess an eventual correlation'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Subcutaneous immunoglobulin', 'Magnetic resonance imaging'], 'conditions': ['Chronic Inflammatory Demyelinating Polyradiculoneuropathy']}, 'descriptionModule': {'briefSummary': 'We want to study whether MRI can be useful in diagnosing and monitoring patients with CIDP in maintenance treatment with immunoglobulin', 'detailedDescription': 'Chronic inflammatory neuropathies such as chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) can be successfully treated with immunoglobulin either intravenously (IVIG) or subcutaneously (SCIG).\n\nCIDP is diagnosed by electrophysiology which is time-consuming and unpleasant for the patient.\n\nNew techniques suggest that Magnetic Resonance Imaging (MRI) and ultrasound imaging can be used to detect injuries in the peripheral nerves\n\nWe want to study if MRI and ultrasound is able to detect damages in peripheral nerves, nerve roots and plexus in patients with CIDP.\n\nMoreover, we want to compare these findings to healthy matched controls and to see if treatment with immunoglobulin changes findings in MRI'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients treated with subcutaneous immunoglobulin for CIDP are invited to participate. They will be recruited from the outpatient clinic at Department of Neurology in Aarhus, Odense and at Rigshospitalet (Copenhagen)\n\nHealthy controls will be recruited by public announcement', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nCIDP patients\n\n* Age \\> 18 and \\< 80 years\n* Diagnosed with definite and probable CIDP and fulfilling the European Federation of Neurological Sciences/Peripheral Nerve Society (EFNS/PNS) criteria\n\nHealthy controls\n\n* Age \\> 18 and \\< 80 years\n* No neurological disorders\n\nExclusion Criteria:\n\n* Age \\< 18 or \\> 80 years\n* Contraindications to MRI\n* Pregnancy\n* Other cause of neuropathy (incl. pressure neuropathy)\n* Diabetes mellitus'}, 'identificationModule': {'nctId': 'NCT02017769', 'briefTitle': 'MRI in Diagnosing and Monitoring CIDP', 'organization': {'class': 'OTHER', 'fullName': 'University of Aarhus'}, 'officialTitle': 'Magnetic Resonance Imaging and Ultrasound Imaging of Peripheral Nerves in Patients Treated With Immunoglobulin in Chronic Inflammatory Demyelinating Polyradiculoneuropathy.', 'orgStudyIdInfo': {'id': '2012-100'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'CIDP - treated', 'description': 'Patients diagnosed with CIDP and fulfilling the criteria by EFNS and PNS and in maintenance treatment with subcutaneous immunoglobulin'}, {'label': 'Healthy controls', 'description': 'Healthy, gender and age matched controls'}, {'label': 'CIDP - untreated', 'description': 'Patients newly diagnosed with CIDP and untreated are treated with immunoglobulin and re-examined after 4 months of treatment'}]}, 'contactsLocationsModule': {'locations': [{'zip': '8000', 'city': 'Aarhus', 'country': 'Denmark', 'facility': 'Department of Neurology, Aarhus University Hospital', 'geoPoint': {'lat': 56.15674, 'lon': 10.21076}}], 'overallOfficials': [{'name': 'Henning Andersen, Prof, DMSc', 'role': 'PRINCIPAL_INVESTIGATOR'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Aarhus', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}