Vasculitis, CNSNCT03166319
Vessel Wall Imaging for Diagnosis and Monitoring of Central Nervous System (CNS) Vasculitis
A study testing MRI, including intracranial vessel wall imaging in people with Vasculitis, CNS and Vasculitis, Cerebral, run by Mayo Clinic at 1 site in United States.
Trial summary
This is a prospective pilot study to determine the utility of MRI and high resolution intracranial vessel wall imaging for the diagnosis and disease activity assessment of intracranial vasculitis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vasculitis, CNS, Vasculitis, Cerebral
- What is being tested?
- MRI, including intracranial vessel wall imaging
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Jul 2017to 24 Nov 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient is determined to have suspected PACNS upon evaluation by a neurologist or rheumatologist or may have an established diagnosis of PACNS of any duration as determined by a neurologist or rheumatologist.
- Ability to undergo routine clinical testing, including lumbar puncture performed for PACNS to exclude potential alternative diagnoses (for initial suspected cases).
- Ability to provide informed consent.
Who cannot join
- Less than 18 years of age.
- Any absolute contraindication to 3 Tesla MRI.
- Any absolute contraindication to gadolinium.
- Contraindication to lumbar puncture such as severe coagulopathy.
- High risk carotid atherosclerotic plaque defined as either greater than 70% stenosis or known high risk plaque features such as intra-plaque hemorrhage.
- Medium or high risk factors for cardioembolic stroke based on the Trial of Org 10172 in Acute Stroke Treatment (TOAST) criteria.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Utility of Intracranial Vessel Wall Imaging for Suspected CNS Vasculitis Diagnosis and Assessment of Disease Activity.
This is a prospective pilot study to determine the utility of MRI and high resolution intracranial vessel wall imaging for the diagnosis and disease activity assessment of intracranial vasculitis.
Read the detailed description
This study will evaluate patients with suspected primary angiitis of the central nervous system (PACNS), recruited during initial work-up by our multi-disciplinary team. Given the low incidence of CNS vasculitis and the fact that some patients are routed to a quaternary care center after initial work-up and diagnosis, evaluation of both groups will be useful to maximize the number of participants evaluated and to provide a representative sample of patients typically treated. During the study, participants will ultimately be deemed to have;
- A specific clinical and pathologic subtype of PACNS,
- PACNS not otherwise specified (NOS) without pathologic or clinical proof of a specific subtype, or
- An alternative diagnosis other than PACNS.
Patients will undergo a standardized imaging and clinical examination at presentation and at pre-defined follow-up periods. Imaging examinations will include an MRI of the head, standard magnetic resonance angiogram (MRA) of the head, and intracranial vessel wall imaging without and with IV gadolinium. Patients will receive up to 4 imaging examinations at predefined intervals as part of this study. MRI/MRA/Vessel wall features will be evaluated by 2 neuroradiologists. Imaging findings will be correlated to clinical and any available laboratory or pathologic data. The target accrual is 10 patients for this pilot study.
- Conditions
- Vasculitis, CNS, Vasculitis, Cerebral
- Being tested
- MRI, including intracranial vessel wall imaging
- Medical subject headings
- Vasculitis, Central Nervous System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI, including intracranial vessel wall imagingDiagnostic test
MRI/MRA/intracranial high-resolution vessel wall imaging (HR-VWI)
| Study group | Role | What they receive |
|---|---|---|
| Suspected CNS Vasculitis | Experimental | Patients with suspected CNS vasculitis will undergo an MRI, including intracranial vessel wall imaging. Receives: Diagnostic Test: MRI, including intracranial vessel wall imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects with Diagnosis of Stroke
Clinical or MRI evidence of stroke on follow-up exam.
Measured: Approximately 5 months after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2017
- Study start24 Jul 2017
- Primary completion24 Nov 2020
- Study completion24 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vasculitis, CNSStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Not applicable
- Intervention model
- Single group
- Model description
- Patients with suspected primary CNS vasculitis.
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vance Lehman, Mayo Clinic
- Investigators
- Vance Lehman, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03166319
- Sponsor's protocol ID
- 16-009297
- Status last verified
- Mar 2022
- First submitted
- 23 May 2017
- Last updated
- 17 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Utility of Intracranial Vessel Wall Imaging for Suspected CNS Vasculitis Diagnosis and Assessment of Disease Activity.
- ClinicalTrials.gov ID
- NCT03166319
- Acronym / sponsor ID
- 16-009297
- Conditions
- Vasculitis, CNS, Vasculitis, Cerebral
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 24 Jul 2017 (actual)
- Primary completion
- 24 Nov 2020 (actual)
- Study completion
- 24 Nov 2020 (actual)
- First posted
- 25 May 2017 (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.
This is a prospective pilot study to determine the utility of MRI and high resolution intracranial vessel wall imaging for the diagnosis and disease activity assessment of intracranial vasculitis.
Detailed description
This study will evaluate patients with suspected primary angiitis of the central nervous system (PACNS), recruited during initial work-up by our multi-disciplinary team. Given the low incidence of CNS vasculitis and the fact that some patients are routed to a quaternary care center after initial work-up and diagnosis, evaluation of both groups will be useful to maximize the number of participants evaluated and to provide a representative sample of patients typically treated. During the study, participants will ultimately be deemed to have;
- A specific clinical and pathologic subtype of PACNS,
- PACNS not otherwise specified (NOS) without pathologic or clinical proof of a specific subtype, or
- An alternative diagnosis other than PACNS.
Patients will undergo a standardized imaging and clinical examination at presentation and at pre-defined follow-up periods. Imaging examinations will include an MRI of the head, standard magnetic resonance angiogram (MRA) of the head, and intracranial vessel wall imaging without and with IV gadolinium. Patients will receive up to 4 imaging examinations at predefined intervals as part of this study. MRI/MRA/Vessel wall features will be evaluated by 2 neuroradiologists. Imaging findings will be correlated to clinical and any available laboratory or pathologic data. The target accrual is 10 patients for this pilot study.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Patients with suspected primary CNS vasculitis.
| Arm | Type | Receives |
|---|---|---|
| Suspected CNS Vasculitis | Experimental | Diagnostic Test: MRI, including intracranial vessel wall imagingPatients with suspected CNS vasculitis will undergo an MRI, including intracranial vessel wall imaging. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- The patient is determined to have suspected PACNS upon evaluation by a neurologist or rheumatologist or may have an established diagnosis of PACNS of any duration as determined by a neurologist or rheumatologist.
- Ability to undergo routine clinical testing, including lumbar puncture performed for PACNS to exclude potential alternative diagnoses (for initial suspected cases).
- Ability to provide informed consent.
Key exclusion criteria (6 listed)
- Less than 18 years of age.
- Any absolute contraindication to 3 Tesla MRI.
- Any absolute contraindication to gadolinium.
- Contraindication to lumbar puncture such as severe coagulopathy.
- High risk carotid atherosclerotic plaque defined as either greater than 70% stenosis or known high risk plaque features such as intra-plaque hemorrhage.
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 |
|---|---|---|
| MRI, including intracranial vessel wall imagingMRI/MRA/intracranial high-resolution vessel wall imaging (HR-VWI) | Diagnostic test | Suspected CNS Vasculitis |
Primary outcome
Number of Subjects with Diagnosis of Stroke
Time frame: Approximately 5 months after baseline
Clinical or MRI evidence of stroke on follow-up exam.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2022.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Vance Lehman, MD principal investigator
Mayo Clinic
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, including intracranial vessel wall imaging in people with Vasculitis, CNS and Vasculitis, Cerebral, run by Mayo Clinic at 1 site in United States.
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 3 inclusion and 6 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: finished, as of the sponsor's last update on 17 Mar 2022. 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 States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Subjects with Diagnosis of Stroke (time frame: Approximately 5 months after baseline). 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 17 Mar 2022.