Ignite Creation Date:
2025-12-25 @ 2:14 AM
Ignite Modification Date:
2025-12-26 @ 7:14 PM
Study NCT ID:
NCT05685160
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-11-15
First Post:
2022-12-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
US and MRI of the Forefoot: Intermetatarsal Bursitis or Morton's Neuroma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000070607', 'term': 'Morton Neuroma'}, {'id': 'D037061', 'term': 'Metatarsalgia'}], 'ancestors': [{'id': 'D005534', 'term': 'Foot Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009437', 'term': 'Neuralgia'}, {'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008279', 'term': 'Magnetic Resonance Imaging'}, {'id': 'D014463', 'term': 'Ultrasonography'}], 'ancestors': [{'id': 'D014054', 'term': 'Tomography'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This is a diagnostic study with a patient and a control group.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 75}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2021-06-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2027-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-13', 'studyFirstSubmitDate': '2022-12-06', 'studyFirstSubmitQcDate': '2023-01-05', 'lastUpdatePostDateStruct': {'date': '2024-11-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-01-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of intermetatarsal bursitis on MRI', 'timeFrame': '8 weeks', 'description': 'High intensity on T2 weighted images, low signal on T1. Thin peripheral enhancement on T1 contrast enhanced pictures.'}, {'measure': 'Incidence of intermetatarsal bursitis on US', 'timeFrame': '8 weeks', 'description': 'Hypoechoic mass between metatarsal heads closest to dorsal surface of foot. Compressible. Activity on power/color doppler.'}, {'measure': "Incidence of Morton's neuroma on MRI", 'timeFrame': '8 weeks', 'description': 'Low to Intermediate signal in T1 and T2. Contrast enhancement of the nodular focus.'}, {'measure': "Incidence of Morton's neuroma on US", 'timeFrame': '8 weeks', 'description': 'Hypoechoic mass between metatarsal heads closest to plantar surface of foot. Non-compressible. The interdigital nerve can be seen entering the mass. Close relation to the interdigital artery.'}, {'measure': 'Incidence of other pathology on MRI', 'timeFrame': '8 weeks', 'description': "Other pathology than intermetatarsal bursitis or Morton's neuroma."}, {'measure': 'Incidence of other pathology on US', 'timeFrame': '8 weeks', 'description': "Other pathology than intermetatarsal bursitis or Morton's neuroma."}, {'measure': 'Incidence of normal findings on MRI', 'timeFrame': '8 weeks', 'description': 'When no findings is observed.'}, {'measure': 'Incidence of normal findings on US', 'timeFrame': '8 weeks', 'description': 'When no findings is observed.'}], 'secondaryOutcomes': [{'measure': 'Opening toes', 'timeFrame': '8 weeks', 'description': 'Presence of opening toes/V-sign/spreading toes.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Forefoot pain', 'Metatarsalgia'], 'conditions': ['Intermetatarsal Bursitis', 'Morton Neuroma', 'Intermetatarsal Neuroma']}, 'descriptionModule': {'briefSummary': "The aim of this study is to investigate the incidence of intermetatarsal bursitis and Morton's neuroma in patients with metatarsalgia (i.e. pain in the forefoot) and control subjects by diagnostic imaging with ultrasound and MRI.", 'detailedDescription': "In a group of patients with intermetatarsal pain found by an orthopedic surgeon, the investigators want to assess the incidences of intermetatarsal bursitis and Morton's neuroma, using diagnostic imaging; ultrasound and MRI.\n\nThe hypothesis is, that intermetatarsal bursitis is an overlooked diagnosis in patients with metatarsalgia. As a result of sparse literature and lack of knowledge about this condition with symptoms mimicking Morton's neuroma, a part of patients diagnosed with Morton's neuroma, suffers from intermetatarsal bursitis instead.\n\nAdditionally, the investigators want to evaluate the clinical sign opening toes.\n\nBased on clinical photos of the feet, the investigators want to document the presence of opening toes and investigate if there is a correlation with either intermetatarsal bursitis and/or Morton's neuroma."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age \\> 18 years\n* Pain in an intermetatarsal space (patient group)\n\nExclusion Criteria:\n\n* Age \\<18 years\n* Open wounds or ongoing infection in the forefoot at the time of examination\n* Persons with contraindications to participate in MRI scan\n* Persons with a history of significant trauma in the forefoot, e.g. any fracture or previous surgeries in the forefoot\n* Persons who have previously received treatment for Morton's neuroma in the same foot, e.g. injection (within 6 months) or operation (anytime)\n* Persons with severely impaired renal function (GFR \\<30 ml/min)\n* Persons with a systemic inflammatory condition like rheumatoid arthritis, due to clinically silent intermetatarsal bursitis in this group (control group)"}, 'identificationModule': {'nctId': 'NCT05685160', 'briefTitle': "US and MRI of the Forefoot: Intermetatarsal Bursitis or Morton's Neuroma", 'organization': {'class': 'OTHER', 'fullName': 'Rigshospitalet, Denmark'}, 'officialTitle': "Ultrasound and MRI of the Forefoot: Intermetatarsal Bursitis or Morton's Neuroma", 'orgStudyIdInfo': {'id': 'H-20067346'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Patient group', 'description': 'Patients with intermetatarsal pain have ultrasound and MRI done', 'interventionNames': ['Diagnostic Test: MRI with contrast', 'Diagnostic Test: Ultrasound']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control group', 'description': 'Healthy individuals (no forefoot pain) undergo ultrasound and MRI scan of the forefoot.', 'interventionNames': ['Diagnostic Test: MRI with contrast', 'Diagnostic Test: Ultrasound']}], 'interventions': [{'name': 'MRI with contrast', 'type': 'DIAGNOSTIC_TEST', 'description': 'MRI of the forefoot with contrast (Gadovist)', 'armGroupLabels': ['Control group', 'Patient group']}, {'name': 'Ultrasound', 'type': 'DIAGNOSTIC_TEST', 'description': 'Ultrasound imaging of the forefoot', 'armGroupLabels': ['Control group', 'Patient group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2100', 'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'Department of Radiology', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rigshospitalet, Denmark', 'class': 'OTHER'}, 'collaborators': [{'name': 'The Danish Rheumatism Association', 'class': 'OTHER'}, {'name': 'Hvidovre University Hospital', 'class': 'OTHER'}, {'name': 'Bispebjerg Hospital', 'class': 'OTHER'}, {'name': 'Gentofte Hospital', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Sif Binder Larsen', 'investigatorAffiliation': 'Rigshospitalet, Denmark'}}}}