Ignite Creation Date:
2025-12-24 @ 5:24 PM
Ignite Modification Date:
2025-12-30 @ 2:11 AM
Study NCT ID:
NCT07098650
Status:
RECRUITING
Last Update Posted:
2025-08-20
First Post:
2025-07-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Haemdall: Developing a Quantitative MRI Biomarker of Infratentorial Superficial Siderosis of the Central Nervous System
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-08-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-14', 'studyFirstSubmitDate': '2025-07-17', 'studyFirstSubmitQcDate': '2025-07-31', 'lastUpdatePostDateStruct': {'date': '2025-08-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-10-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To evaluate the association and clinical relevance of with markers of neurodegeneration and clinical assessments', 'timeFrame': 'through study completion, an average of 1 year', 'description': '1. Correlation between magnetic susceptibility assessed by QSM and brain cognitive function by MoCA.\n2. Correlations between magnetic susceptibility assessed by QSM and: a) markers of neurodegeneration; and b) clinical assessment outcomes (auditory, balance, gait, cognitive)'}], 'secondaryOutcomes': [{'measure': 'Radiologist observational scoring and test-retest', 'timeFrame': 'through study completion, an average of 1 year', 'description': '1. The agreement between radiologist scored observational level of iron accumulation via the Queens Square Superficial Siderosis (QUASARS) rating scale and quantitative MRI measure related to iron on the brain surface. The QUASARS rating is out of 36 points; with higher scores indicate a worse outcome\n2. The repeatability coefficient within a single scanning session'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['brain iron', 'MRI', 'Quantitative Susceptibility Mapping'], 'conditions': ['Superficial Siderosis']}, 'descriptionModule': {'briefSummary': "Haemdall: Using Medical Imaging to measure Brain Iron in Superficial Siderosis.\n\nThis study is looking at a new way of using MRI scans to potentially measure the amount of iron on the surface of the brain. Iron build up in the brain is linked to how superficial siderosis develops. The study will also aim to see if there is a connection between the amount of iron in the brain and common superficial siderosis symptoms. Clinical tests will be used to measure symptoms including tests to measure your hearing, walking \\& balance and participants' ability to remember, think and understand."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '50 participants from around the UK', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\nSuperficial siderosis cohort:\n\n* Male or female adults of 18 years of age or older with a confirmed diagnosis of superficial siderosis\n* Participants who have the capacity and a level of English proficiency that allows him/her to communicate well with the Investigator, understand and comply with the requirements of the investigation, read all participant facing documentation, as well as read and sign the informed consent form.\n* Participants willing and able to give informed consent for participation in the investigation\n\nHealthy cohort:\n\n* Male or female over 18 years of age without a diagnosis of a neurological disorder\n* Participants who have the capacity and a level of English proficiency that allows him/her to communicate well with the Investigator, understand and comply with the requirements of the investigation, read all participant facing documentation, as well as read and sign the informed consent form.\n* Participants willing and able to give informed consent for participation in the investigation\n\nExclusion Criteria:\n\n* The participant may not enter the investigation if they have any contraindication to magnetic resonance imaging (including pregnancy, extensive tattoos, pacemaker, shrapnel injury or metallic unfixed implanted devices, metallic fragments, severe claustrophobia and cochlear implants)\n* Any other cause, including a significant disease or disorder which, in the opinion of the investigator, may either put the participant at risk because of participation in the investigation, or may influence the result of the investigation, or the participant's ability to participate in the investigation\n* Participants who do not demonstrate the capacity to understand the investigation information or provide informed consent"}, 'identificationModule': {'nctId': 'NCT07098650', 'acronym': 'Haemdall', 'briefTitle': 'Haemdall: Developing a Quantitative MRI Biomarker of Infratentorial Superficial Siderosis of the Central Nervous System', 'organization': {'class': 'INDUSTRY', 'fullName': 'Perspectum'}, 'officialTitle': 'Haemdall: Developing a Quantitative MRI Biomarker of Classical (Infratentorial) Superficial Siderosis of the Central Nervous System', 'orgStudyIdInfo': {'id': '24/PR/1441'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Superficial siderosis cohort', 'description': 'Individuals diagnosed with infratentorial superficial siderosis'}, {'label': 'Healthy volunteer cohort', 'description': 'Healthy volunteers without other neurological condition or significant disease'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'OX4 2LL', 'city': 'Oxford', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Haemdall Study Inbox Study Inbox', 'role': 'CONTACT', 'email': 'brainiron@perspectum.com', 'phone': '+44 (0) 1865 655 343'}, {'name': 'Susannah Krzyzanowski', 'role': 'CONTACT', 'email': 'susannah.krzyzanowski@perspectum.com'}, {'name': 'Mahd Siddiqi', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Perspectum', 'geoPoint': {'lat': 51.75222, 'lon': -1.25596}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Perspectum', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}