Haemdall: Developing a Quantitative MRI Biomarker of Infratentorial Superficial Siderosis of the Central Nervous System

NCT07098650 | Recruiting

• 1 other identifier: 24/PR/1441
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Haemdall: Using Medical Imaging to measure Brain Iron in Superficial Siderosis. This 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.

Conditions

Superficial Siderosis

Keywords

brain iron; MRI; Quantitative Susceptibility Mapping

Outcome Measures

Primary Outcomes (1)

• To evaluate the association and clinical relevance of with markers of neurodegeneration and clinical assessments

  1. Correlation between magnetic susceptibility assessed by QSM and brain cognitive function by MoCA. 2. Correlations between magnetic susceptibility assessed by QSM and: a) markers of neurodegeneration; and b) clinical assessment outcomes (auditory, balance, gait, cognitive)

  through study completion, an average of 1 year

Secondary Outcomes (1)

• Radiologist observational scoring and test-retest

  through study completion, an average of 1 year

Study Arms (2)

Superficial siderosis cohort

Individuals diagnosed with infratentorial superficial siderosis

Healthy volunteer cohort

Healthy volunteers without other neurological condition or significant disease

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

50 participants from around the UK

You may qualify if:

• Superficial siderosis cohort:
• Male or female adults of 18 years of age or older with a confirmed diagnosis of superficial siderosis
• 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.
• Participants willing and able to give informed consent for participation in the investigation
• Healthy cohort:
• Male or female over 18 years of age without a diagnosis of a neurological disorder
• 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.
• Participants willing and able to give informed consent for participation in the investigation

You may not qualify if:

• 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)
• 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
• Participants who do not demonstrate the capacity to understand the investigation information or provide informed consent

Sponsors & Collaborators

• Perspectum: lead

Study Sites (1)

Perspectum

Oxford, OX4 2LL, United Kingdom

RECRUITING

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2025
• First Posted: August 1, 2025
• Study Start: August 14, 2025
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: August 20, 2025

Record last verified: 2025-08

Locations

GB (1)