Ignite Creation Date:
2025-12-25 @ 2:14 AM
Ignite Modification Date:
2026-01-19 @ 2:56 AM
Study NCT ID:
NCT00658060
Status:
UNKNOWN
Last Update Posted:
2008-04-14
First Post:
2008-04-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Magnetic Resonance (MR) Spectroscopy In Familial Mediterranean Fever (FMF) Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010505', 'term': 'Familial Mediterranean Fever'}], 'ancestors': [{'id': 'D056660', 'term': 'Hereditary Autoinflammatory Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2007-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-04', 'lastUpdateSubmitDate': '2008-04-11', 'studyFirstSubmitDate': '2008-04-08', 'studyFirstSubmitQcDate': '2008-04-11', 'lastUpdatePostDateStruct': {'date': '2008-04-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-04-14', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'change in spectroscopic appearance of muscle after exertion of muscle thigh', 'timeFrame': '1 hour'}], 'secondaryOutcomes': [{'measure': 'change in muscle intensity signal after exertion', 'timeFrame': '1 hour'}, {'measure': 'change in joint effusion status after exertion', 'timeFrame': '1 hour'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['FMF, Exertional leg pain'], 'conditions': ['Familial Mediterranean Fever']}, 'referencesModule': {'references': [{'pmid': '11407703', 'type': 'BACKGROUND', 'citation': 'Brik R, Shinawi M, Kasinetz L, Gershoni-Baruch R. The musculoskeletal manifestations of familial Mediterranean fever in children genetically diagnosed with the disease. Arthritis Rheum. 2001 Jun;44(6):1416-9. doi: 10.1002/1529-0131(200106)44:63.0.CO;2-6.'}, {'pmid': '16585908', 'type': 'BACKGROUND', 'citation': 'Bendahan D, Mattei JP, Guis S, Kozak-Ribbens G, Cozzone PJ. [Non-invasive investigation of muscle function using 31P magnetic resonance spectroscopy and 1H MR imaging]. Rev Neurol (Paris). 2006 Apr;162(4):467-84. doi: 10.1016/s0035-3787(06)75038-x. French.'}]}, 'descriptionModule': {'briefSummary': 'Familial Mediterranean fever (FMF) is an inherited disorder of unknown etiology, characterized by recurrent episodes of fever, peritonitis and/or pleuritis.\n\nFever is the cardinal manifestation of FMF and is present in most attacks accompanied by abdominal pain.\n\nAnother clinical manifestation in patients with FMF is exertional muscle pain, usually in the thigh, which appears even after minor exercise or physical activity in young patients with generally good health (other than FMF) and in good physical condition. Some patients also complain of ankle edema after relatively minor physical activity, which subsides after a night rest. Although these manifestations are quite common in FMF patients and form part of the minor criteria for the diagnosis, the etiopathogenesis has not been examined.\n\nThe purpose of the suggested study is to evaluate and characterize the anatomical and biochemical changes in the muscles of the thigh and in the ankle triggered by physical activity in FMF patients complaining of exertional lower leg myalgias and edema after minor physical exercise.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with FMF, fulfilling the Tel Hashomer criteria for the diagnosis of FMF, suffering from episodes of exertional leg pain and or exertional ankle edema, 18-45 years old, on a stable (≥ 2 weeks) dose of oral colchicine therapy, Non-smokers', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Fulfilling the Tel Hashomer criteria for the diagnosis of FMF \\[5\\].\n2. Suffering from episodes of exertional leg pain and or exertional ankle edema\n3. 18-45 years old\n4. On a stable (≥ 2 weeks) dose of oral colchicine therapy\n5. Non-smokers\n\nExclusion Criteria:\n\n1. with known peripheral vascular disease (PVD) and/or multiple risk factors for PVD (such as diabetes, hypertension, hyperlipidemia)\n2. Suffering from muscular or neurological diseases not related to FMF\n3. With elevated serum creatinine / liver enzymes/ creatine phosphokinase (CPK) levels.\n4. Suffering from claustrophobia, or with metal fragments in body tissue, or with other contraindications for MRI.'}, 'identificationModule': {'nctId': 'NCT00658060', 'briefTitle': 'Magnetic Resonance (MR) Spectroscopy In Familial Mediterranean Fever (FMF) Patients', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Sheba Medical Center'}, 'officialTitle': 'Exertional Muscle Fatigue In FMF Patients Evaluated By MRI And MR Spectroscopy Of The Thigh', 'orgStudyIdInfo': {'id': 'SHEBA-07-4632-IE-CTIL'}}, 'armsInterventionsModule': {'armGroups': [{'label': '1', 'description': '* 1.Fulfilling the Tel Hashomer criteria for the diagnosis of FMF \\[5\\].\n* 2.Suffering from episodes of exertional leg pain and or exertional ankle edema\n* 3.18-45 years old\n* 4.On a stable (≥ 2 weeks) dose of oral colchicine therapy\n* 5.Non-smokers'}, {'label': '2', 'description': 'Control group\n\n* 1.Healthy subjects\n* 2.18-45 years old\n* 3.Non-smokers'}]}, 'contactsLocationsModule': {'locations': [{'zip': '52621', 'city': 'Ramat Gan', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Iris Eshed', 'role': 'CONTACT'}], 'facility': 'Sheba Medical Center', 'geoPoint': {'lat': 32.08227, 'lon': 34.81065}}], 'centralContacts': [{'name': 'Merav Lidar, MD', 'role': 'CONTACT', 'email': 'merav.lidar@sheba.health.gov.il', 'phone': '+972-54-4721675'}], 'overallOfficials': [{'name': 'Iris Eshed, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sheba Medical Center'}, {'name': 'Tammi Kushnir, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sheba Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sheba Medical Center', 'class': 'OTHER_GOV'}, 'responsibleParty': {'oldNameTitle': 'Eshed Iris, MD', 'oldOrganization': 'Sheba Medical Center'}}}}