Moyamoya DiseaseIMAGINENCT06330818
Imaging in Moyamoya Disease - Study to Investigate Different Imaging Technologies for a Better Understanding of Various Imaging Techniques to Evaluate Cerebral Hemodynamics, Disease-activity and Possibly the Etiology in Moyamoya Patients
A study testing MRI, H2 15O PET/CT and Biosampling in people with Moyamoya Disease and Moyamoya, run by University Hospital Tuebingen at 1 site in Germany.
Trial summary
Aim of this study is to improve patient care in Moyamoya Patients by improving Imaging technologies and aiming to identify factors involved in disease progression. Main tasks are: Analysis of CO2-triggered BOLD fMRI for analysis of cerebral hemodynamics in comparison to H2 15O PET/CT Analysis of longitudinal changes… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Moyamoya Disease, Moyamoya
- What is being tested?
- MRI, H2 15O PET/CT and Biosampling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jul 2024to 30 Nov 2027
- Phase
- Interventional
- 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with suspicion of Moyamoya Disease
- Patients able to understand the study and to give their informed consent
Who cannot join
- Cerebral vascular disease caused by atherosclerosis
- Vasculitis
- Contraindications to MRI
- Contraindications to PET/CT
- Pregnancy
- Inability to give informed consent
- Renal insufficiency
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
University of Tuebingen, Neurosurgery
Tübingen, Baden-Wurttemberg, 72076
Constantin Roder, Prof. Dr., MD, 07071-290, constantin.roder@med.uni-tuebingen.de
About this study
Official title: IMAGINE - Imaging in Moyamoya Disease
Aim of this study is to improve patient care in Moyamoya Patients by improving Imaging technologies and aiming to identify factors involved in disease progression.
Main tasks are:
- Analysis of CO2-triggered BOLD fMRI for analysis of cerebral hemodynamics in comparison to H2 15O PET/CT
- Analysis of longitudinal changes of contrast enhancement in vessel-wall imaging and correlation of disease activity with biosampling
- Definition of a standardized recommendation for pre- and postoperative imaging of Moyamoya patients
Read the detailed description
Moyamoya Disease (MMD) is a rare disease defined by a bilateral stenosis or occlusion of the terminal internal carotid artery (ICA) and proximal arteries of the circle of willis. The stenosis is usually accompanied by fine collateral vessels appearing as "a puff of smoke" on conventional DSA giving the disease its name (Japanese). The disease is known to progress over time in 20-40% of adult patients, also to initially not affected vessels. To prevent from ischemic or hemorrhagic strokes, most patients need microsurgical revascularization with extracranial-intracranial (EC-IC) bypasses for the affected cerebrovascular territories. The indication for a possible revascularization should always be decided based on functional imaging identifying cerebrovascular territories with an insufficient reserve capacity. The "gold-standard" for measuring the cerebrovascular reserve is H2 15O PET/CT with Acetazolamide challenge (ACZ), whereat also SPECT and different MRI techniques are used but with less sensitivity. Main drawback of H2 15O PET/CT is its very limited availability, high costs, the need to inject ACZ and radiation exposure. Further, the costs of H2 15O PET/CT for Moyamoya patients are not covered by the German health insurance system as no valid high-quality studies are available to prove a possible benefit of this examination.
Throughout the last years the investigators have focused our research on different MRI techniques in Moyamoya patients aiming to find reliable examinations for the evaluation of the cerebral blood flow and to detect and monitor disease progression:
The investigators' newly developed semi-automated algorithms for the evaluation of CO2-triggered BOLD MRI (breathhold fMRI) sequences to identify a reduced vasoreactivity showed a promisingly high correlation to the results of the cerebrovascular reserve measurements as seen in PET/CT. Further, the investigators were able to show that disease progression can be predicted by a temporary contrast enhancement of the vessel wall seen over approximately 24 months as high-resolution vessel-wall imaging was performed consequently in all patients.
Therefore, the main goals of this study are to improve patient care in Moyamoya patients with the following three key elements:
- Defining the value of CO2 triggered BOLD MRI in the evaluation of cerebral hemodynamics pre- and postoperatively compared to H2 15O PET/CT aiming to possibly prove or reduce the need for PET/CT examinations.
- Understanding radiographic and pathophysiologic processes causing disease progression as seen by vessel-wall imaging to enable timely revascularization or possibly non-surgical treatment of this disease in the future.
- Possible new insights in disease-pathophysiology and progression as seen in vessel wall imaging by correlating imaging results with biosampling (peripheral blood
- Defining a standardized recommendation for pre- and postoperative hemodynamic and MR-morphologic evaluation of Moyamoya patients based on the results of this study.
As secondary objectives the following elements will be analyzed:
- Neuropsychological impairment in correlation to the hemodynamic and MR-morphologic status of the brain.
- Feasibility of resting-state fMRI to evaluate cerebral vasoreactivity.
To achieve these goals, the investigators are planning to prospectively include 50 Moyamoya patients in this study with a standardized imaging, neuropsychological testing and biosampling protocol with a two-year follow-up. Under the assumption of a homogenous inclusion of patients, recruitment should be finished after two years with one year of follow-up after the inclusion of the last patient. This cohort will provide reliable information on standardized diagnostic patterns and possibly a broader understanding of pathophysiology causing disease development and progression.
- Conditions
- Moyamoya Disease, Moyamoya
- Being tested
- MRI, H2 15O PET/CT, Biosampling
- Keywords
- Stroke, Moyamoya, EC-IC Bypass
- Medical subject headings
- Moyamoya Disease, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIDiagnostic test
Patients will get special MRI sequences (CO2-triggered BOLD MRI, Vessel-wall imaging, resting state BOLD MRI) to identify cerebral vasoreactivity and disease activity.
H2 15O PET/CTDiagnostic test
Patients will get H2 15O PET/CT with acetazolamide challenge to define the cerebral vasoreserve for comparison with fMRI Images
BiosamplingOther
Patients do get a venous puncture for blood analysis on circulating endothelial cells and virus PCR analysis
| Study group | Role | What they receive |
|---|---|---|
| Moyamoya patients | Experimental | Newly diagnosed Moyamoya patients who will follow a standardized imaging and biosampling protocol. Possible surgical or conservative treatment will not be influenced by this study. Receives: Diagnostic Test: MRI; Diagnostic Test: H2 15O PET/CT; Other: Biosampling |
| Control group | No intervention | Healthy patients and patients with intracerebral atherosclerotic disease are used as comparators for the results of biosampling. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Value of CO2-triggered BOLD MRI compared to PET/CT
Analysis of comparability of fMRI-based vasoreactivity and PET/CT based vasoreserve (Signal change in percent)
Measured: From enrollment until maximum of 24 months
Secondary outcomes (3)
Vessel-Wall contrast enhancement
Analysis of vessel-wall contrast enhancement as predictor for disease-activity (Intensity of contrast enhancement relative to reference tissue on MRI)
Measured: From enrollment until maximum of 24 months
Circulating endothelial cells
FACS-based analysis of circulating endothelial cells as indicator for disease activity (absolute number of respective circulating endothelial cells subgroup)
Measured: From enrollment to a maximum of 24 months
PCR-based virus sampling
Analysis of possible virus infections as indicator for disease etiology (absolute number of Virus DNA based on PCR results)
Measured: From enrollment until maximum 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2024
- Study start1 Jul 2024
- Primary completion30 Jul 2027 (estimated)
- Study completion30 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Moyamoya DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital TuebingenThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital Freiburg
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06330818
- Sponsor's protocol ID
- IMAGINE Moyamoya
- Other IDs
- 528291394
- Acronym
- IMAGINE
- Status last verified
- Mar 2024
- First submitted
- 12 Mar 2024
- Last updated
- 26 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD will be made available anonymized upon reasonable request
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IMAGINE - Imaging in Moyamoya Disease
- ClinicalTrials.gov ID
- NCT06330818
- Acronym / sponsor ID
- IMAGINE / IMAGINE Moyamoya
- Conditions
- Moyamoya Disease, Moyamoya
- Keywords
- Stroke, Moyamoya, EC-IC Bypass
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Collaborators
- University Hospital Freiburg
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 30 Jul 2027 (estimated)
- Study completion
- 30 Nov 2027 (estimated)
- First posted
- 26 Mar 2024 (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.
Aim of this study is to improve patient care in Moyamoya Patients by improving Imaging technologies and aiming to identify factors involved in disease progression.
Main tasks are:
- Analysis of CO2-triggered BOLD fMRI for analysis of cerebral hemodynamics in comparison to H2 15O PET/CT
- Analysis of longitudinal changes of contrast enhancement in vessel-wall imaging and correlation of disease activity with biosampling
- Definition of a standardized recommendation for pre- and postoperative imaging of Moyamoya patients
Detailed description
Moyamoya Disease (MMD) is a rare disease defined by a bilateral stenosis or occlusion of the terminal internal carotid artery (ICA) and proximal arteries of the circle of willis. The stenosis is usually accompanied by fine collateral vessels appearing as "a puff of smoke" on conventional DSA giving the disease its name (Japanese). The disease is known to progress over time in 20-40% of adult patients, also to initially not affected vessels. To prevent from ischemic or hemorrhagic strokes, most patients need microsurgical revascularization with extracranial-intracranial (EC-IC) bypasses for the affected cerebrovascular territories. The indication for a possible revascularization should always be decided based on functional imaging identifying cerebrovascular territories with an insufficient reserve capacity. The "gold-standard" for measuring the cerebrovascular reserve is H2 15O PET/CT with Acetazolamide challenge (ACZ), whereat also SPECT and different MRI techniques are used but with less sensitivity. Main drawback of H2 15O PET/CT is its very limited availability, high costs, the need to inject ACZ and radiation exposure. Further, the costs of H2 15O PET/CT for Moyamoya patients are not covered by the German health insurance system as no valid high-quality studies are available to prove a possible benefit of this examination.
Throughout the last years the investigators have focused our research on different MRI techniques in Moyamoya patients aiming to find reliable examinations for the evaluation of the cerebral blood flow and to detect and monitor disease progression:
The investigators' newly developed semi-automated algorithms for the evaluation of CO2-triggered BOLD MRI (breathhold fMRI) sequences to identify a reduced vasoreactivity showed a promisingly high correlation to the results of the cerebrovascular reserve measurements as seen in PET/CT. Further, the investigators were able to show that disease progression can be predicted by a temporary contrast enhancement of the vessel wall seen over approximately 24 months as high-resolution vessel-wall imaging was performed consequently in all patients.
Therefore, the main goals of this study are to improve patient care in Moyamoya patients with the following three key elements:
- Defining the value of CO2 triggered BOLD MRI in the evaluation of cerebral hemodynamics pre- and postoperatively compared to H2 15O PET/CT aiming to possibly prove or reduce the need for PET/CT examinations.
- Understanding radiographic and pathophysiologic processes causing disease progression as seen by vessel-wall imaging to enable timely revascularization or possibly non-surgical treatment of this disease in the future.
- Possible new insights in disease-pathophysiology and progression as seen in vessel wall imaging by correlating imaging results with biosampling (peripheral blood
- Defining a standardized recommendation for pre- and postoperative hemodynamic and MR-morphologic evaluation of Moyamoya patients based on the results of this study.
As secondary objectives the following elements will be analyzed:
- Neuropsychological impairment in correlation to the hemodynamic and MR-morphologic status of the brain.
- Feasibility of resting-state fMRI to evaluate cerebral vasoreactivity.
To achieve these goals, the investigators are planning to prospectively include 50 Moyamoya patients in this study with a standardized imaging, neuropsychological testing and biosampling protocol with a two-year follow-up. Under the assumption of a homogenous inclusion of patients, recruitment should be finished after two years with one year of follow-up after the inclusion of the last patient. This cohort will provide reliable information on standardized diagnostic patterns and possibly a broader understanding of pathophysiology causing disease development and progression.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Moyamoya patients | Experimental | Diagnostic Test: MRI, Diagnostic Test: H2 15O PET/CT, Other: BiosamplingNewly diagnosed Moyamoya patients who will follow a standardized imaging and biosampling protocol. Possible surgical or conservative treatment will not be influenced by this study. |
| Control group | No intervention | –Healthy patients and patients with intracerebral atherosclerotic disease are used as comparators for the results of biosampling. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with suspicion of Moyamoya Disease
- Patients able to understand the study and to give their informed consent
Key exclusion criteria (7 listed)
- Cerebral vascular disease caused by atherosclerosis
- Vasculitis
- Contraindications to MRI
- Contraindications to PET/CT
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRIPatients will get special MRI sequences (CO2-triggered BOLD MRI, Vessel-wall imaging, resting state BOLD MRI) to identify cerebral vasoreactivity and disease activity. | Diagnostic test | Moyamoya patients |
| H2 15O PET/CTPatients will get H2 15O PET/CT with acetazolamide challenge to define the cerebral vasoreserve for comparison with fMRI Images | Diagnostic test | Moyamoya patients |
| BiosamplingPatients do get a venous puncture for blood analysis on circulating endothelial cells and virus PCR analysis | Other | Moyamoya patients |
Primary outcome
Value of CO2-triggered BOLD MRI compared to PET/CT
Time frame: From enrollment until maximum of 24 months
Analysis of comparability of fMRI-based vasoreactivity and PET/CT based vasoreserve (Signal change in percent)
3 secondary outcomes
Vessel-Wall contrast enhancement
Time frame: From enrollment until maximum of 24 months
Circulating endothelial cells
Time frame: From enrollment to a maximum of 24 months
PCR-based virus sampling
Time frame: From enrollment until maximum 24 months
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 26 Sep 2024.
- Individual participant dataSharing planned: Yes. IPD will be made available anonymized upon reasonable request
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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?
A study testing MRI, H2 15O PET/CT and Biosampling in people with Moyamoya Disease and Moyamoya, run by University Hospital Tuebingen at 1 site in Germany.
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 2 inclusion and 7 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 26 Sep 2024. 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 Germany. 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?
Contact Constantin Roder, Prof. Dr., MD (0049-7071290, constantin.roder@med.uni-tuebingen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Value of CO2-triggered BOLD MRI compared to PET/CT (time frame: From enrollment until maximum of 24 months). 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 26 Sep 2024.