Superficial SiderosisHaemdallNCT07098650
Haemdall: Developing a Quantitative MRI Biomarker of Infratentorial Superficial Siderosis of the Central Nervous System
An observational study of Superficial Siderosis, run by Perspectum at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Superficial Siderosis
- How many people
- 50 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 14 Aug 2025to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 50 participants from around the UK
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
Perspectum
Oxford, OX4 2LL
Haemdall Study Inbox Study Inbox, +44 (0) 1865 655 343, brainiron@perspectum.com
Susannah Krzyzanowski, susannah.krzyzanowski@perspectum.com
About this study
Official title: Haemdall: Developing a Quantitative MRI Biomarker of Classical (Infratentorial) Superficial Siderosis of the Central Nervous System
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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Superficial siderosis cohort | Individuals diagnosed with infratentorial superficial siderosis | |
| Healthy volunteer cohort | Healthy volunteers without other neurological condition or significant disease |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the association and clinical relevance of with markers of neurodegeneration and clinical assessments
- Correlation between magnetic susceptibility assessed by QSM and brain cognitive function by MoCA.
- Correlations between magnetic susceptibility assessed by QSM and: a) markers of neurodegeneration; and b) clinical assessment outcomes (auditory, balance, gait, cognitive)
Measured: through study completion, an average of 1 year
Secondary outcomes (1)
Radiologist observational scoring and test-retest
- 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
- The repeatability coefficient within a single scanning session
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2025
- Study start14 Aug 2025
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Superficial SiderosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Perspectum
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07098650
- Sponsor's protocol ID
- 24/PR/1441
- Acronym
- Haemdall
- Status last verified
- Aug 2025
- First submitted
- 17 Jul 2025
- Last updated
- 20 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Haemdall: Developing a Quantitative MRI Biomarker of Classical (Infratentorial) Superficial Siderosis of the Central Nervous System
- ClinicalTrials.gov ID
- NCT07098650
- Acronym / sponsor ID
- Haemdall / 24/PR/1441
- Conditions
- Superficial Siderosis
- Keywords
- brain iron, MRI, Quantitative Susceptibility Mapping
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- PerspectumIndustry (pharma, biotech, devices)
- Study start
- 14 Aug 2025 (actual)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 1 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Superficial siderosis cohort | – | –Individuals diagnosed with infratentorial superficial siderosis |
| Healthy volunteer cohort | – | –Healthy volunteers without other neurological condition or significant disease |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 50 participants from around the UK
Key inclusion criteria (8 listed)
- 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
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To evaluate the association and clinical relevance of with markers of neurodegeneration and clinical assessments
Time frame: through study completion, an average of 1 year
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)
1 secondary outcome
Radiologist observational scoring and test-retest
Time frame: through study completion, an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Superficial Siderosis, run by Perspectum at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the association and clinical relevance of with markers of neurodegeneration and clinical assessments (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2025.