Large Vessel VasculitisNCT03914248
Monitoring Large Vessel Vasculitis With PET/MR Imaging
An observational study of Large Vessel Vasculitis, run by University of Edinburgh at 1 site in United Kingdom.
Trial summary
Large vessel vasculitis (LVV) causes blood vessel inflammation leading to pain, fatigue and complications such as aneurysm formation and stroke. Treatments used can have significant side-effects. Doctors find it difficult to determine when to start and stop treatment, often leading to over- or under-treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Large Vessel Vasculitis
- How many people
- 27 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Jul 2019to 26 Jan 2022
- Phase
- Observational
- 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
Study population: Participants will be recruited from outpatient clinics throughout Scotland
Who may be able to join
- A new diagnosis of LVV or a known diagnosis of LVV presenting with disease relapse
Who cannot join
- Predominantly cranial symptoms
- LVV secondary to other conditions
- Treatment with high dose glucocorticoids for >2 weeks at time of recruitment
- Contraindication to MR or PET
- Unable to travel to Edinburgh
- Estimated glomerular filtration rate (eGFR) <30 ml/min/1.73m2
- Unable to provide informed consent
- Pregnant or breastfeeding
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Monitoring Large Vessel Vasculitis With PET/MR Imaging: an Exploratory Study
Large vessel vasculitis (LVV) causes blood vessel inflammation leading to pain, fatigue and complications such as aneurysm formation and stroke. Treatments used can have significant side-effects. Doctors find it difficult to determine when to start and stop treatment, often leading to over- or under-treatment. A new test is required to determine disease activity that will guide treatment more accurately. This study will recruit participants with active LVV from throughout Scotland in order to assess the ability of two new types of scan - positron emission tomography with magnetic resonance imaging (PET/MR) and retinal optical coherence tomography (OCT) - to determine disease activity. In addition, I will investigate the link between LVV and heart disease.
Read the detailed description
Large vessel vasculitis (LVV) is a multi-system, autoimmune disease characterised by non-specific symptoms, pain and high glucocorticoid requirements. The lack of a robust biomarker that tracks disease activity makes disease monitoring difficult. This leads to both disease over-treatment, resulting in adverse effects of glucocorticoids, and under-treatment, with the potential for significant vascular complications. Additionally, the link between LVV and cardiovascular disease (CVD), which is the main cause of death in these patients, remains poorly characterised. An imaging tool which is capable of accurately monitoring disease activity over time is urgently required. Positron emission tomography with magnetic resonance imaging (PET/MR) and retinal optical coherence tomography (OCT) have the potential to meet this need. PET/MR is uniquely useful for imaging CVD and utilises ~50% of the radiation dose of PET with computerised tomography. OCT is a novel potential biomarker of microvascular dysfunction, systemic inflammation and CVD risk in small vessel vasculitis. Participants with a new diagnosis or recent flare of LVV will undergo serial PET/MR and OCT scanning alongside established measures of CVD risk. Results will be compared with current clinical measures of disease activity and with banked control data.
- Conditions
- Large Vessel Vasculitis
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 |
|---|---|---|
| Active large vessel vasculitis | PET/MR scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum standardised uptake values (SUVmax)
Maximum standardised uptake values (SUVmax) will be assessed using PETMR. This information will be used to quantify disease activity and atheroma at pre-specified vascular segments.
Measured: 0 and 6 months
Secondary outcomes (5)
Choroidal thickness in microns
Assessment of choroidal thickness as measured using optical coherence tomography will be made at baseline and 6 months
Measured: 0 and 6 months
Choroidal volume in mm3
Assessment of choroidal volume using optical coherence tomography will be made at baseline and 6 months
Measured: 0 and 6 months
Retinal vasculature morphology
Visual assessment of arteriolar thickness, branching coefficient and branching angle, fractal dimension, and venular tortuosity will be made using OPTOS imaging at baseline and 6 months
Measured: 0 and 6 months
24-hour ambulatory blood pressure in mmHg
Assessment of 24-hour ambulatory systolic and diastolic blood pressure will be made at baseline and 6 months
Measured: 0 and 6 months
Pulse wave velocity
Assessment of arterial stiffness will be made using pulse wave velocity as measured using SphygmoCor technology. Percentage change in pulse wave velocity will be compared between baseline and 6 months
Measured: 0 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2019
- Study start1 Jul 2019
- Primary completion26 Jan 2022
- Study completion26 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Large Vessel VasculitisStudies of the same condition, open and under way.
- More trials run by University of EdinburghThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Edinburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Neeraj Dhaun, MBChB PhD, Principal investigator, University of Edinburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03914248
- Sponsor's protocol ID
- E182026
- Status last verified
- May 2022
- First submitted
- 2 Apr 2019
- Last updated
- 24 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Pugh D, Patel D, Macnaught G, Czopek A, Bruce L, Donachie J, Gallacher PJ, Tan S, Ahlman M, Grayson PC, Basu N, Dhaun N. 18F-FDG-PET/MR imaging to monitor disease activity in large vessel vasculitis. Nat Commun. 2024 Aug 25;15(1):7314. doi: 10.1038/s41467-024-51613-1.
PubMed 39183340
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monitoring Large Vessel Vasculitis With PET/MR Imaging: an Exploratory Study
- ClinicalTrials.gov ID
- NCT03914248
- Acronym / sponsor ID
- E182026
- Conditions
- Large Vessel Vasculitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- University of EdinburghUniversity, hospital or other
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 26 Jan 2022 (actual)
- Study completion
- 26 Jan 2022 (actual)
- First posted
- 16 Apr 2019 (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.
Large vessel vasculitis (LVV) causes blood vessel inflammation leading to pain, fatigue and complications such as aneurysm formation and stroke. Treatments used can have significant side-effects. Doctors find it difficult to determine when to start and stop treatment, often leading to over- or under-treatment. A new test is required to determine disease activity that will guide treatment more accurately. This study will recruit participants with active LVV from throughout Scotland in order to assess the ability of two new types of scan - positron emission tomography with magnetic resonance imaging (PET/MR) and retinal optical coherence tomography (OCT) - to determine disease activity. In addition, I will investigate the link between LVV and heart disease.
Detailed description
Large vessel vasculitis (LVV) is a multi-system, autoimmune disease characterised by non-specific symptoms, pain and high glucocorticoid requirements. The lack of a robust biomarker that tracks disease activity makes disease monitoring difficult. This leads to both disease over-treatment, resulting in adverse effects of glucocorticoids, and under-treatment, with the potential for significant vascular complications. Additionally, the link between LVV and cardiovascular disease (CVD), which is the main cause of death in these patients, remains poorly characterised. An imaging tool which is capable of accurately monitoring disease activity over time is urgently required. Positron emission tomography with magnetic resonance imaging (PET/MR) and retinal optical coherence tomography (OCT) have the potential to meet this need. PET/MR is uniquely useful for imaging CVD and utilises ~50% of the radiation dose of PET with computerised tomography. OCT is a novel potential biomarker of microvascular dysfunction, systemic inflammation and CVD risk in small vessel vasculitis. Participants with a new diagnosis or recent flare of LVV will undergo serial PET/MR and OCT scanning alongside established measures of CVD risk. Results will be compared with current clinical measures of disease activity and with banked control data.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Active large vessel vasculitis | – | –PET/MR scan |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will be recruited from outpatient clinics throughout Scotland
Key inclusion criteria (1 listed)
- A new diagnosis of LVV or a known diagnosis of LVV presenting with disease relapse
Key exclusion criteria (8 listed)
- Predominantly cranial symptoms
- LVV secondary to other conditions
- Treatment with high dose glucocorticoids for >2 weeks at time of recruitment
- Contraindication to MR or PET
- Unable to travel to Edinburgh
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
Maximum standardised uptake values (SUVmax)
Time frame: 0 and 6 months
Maximum standardised uptake values (SUVmax) will be assessed using PETMR. This information will be used to quantify disease activity and atheroma at pre-specified vascular segments.
5 secondary outcomes
Choroidal thickness in microns
Time frame: 0 and 6 months
Choroidal volume in mm3
Time frame: 0 and 6 months
Retinal vasculature morphology
Time frame: 0 and 6 months
24-hour ambulatory blood pressure in mmHg
Time frame: 0 and 6 months
Pulse wave velocity
Time frame: 0 and 6 months
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 24 May 2022.
- Derived from this study: PubMed 39183340Pugh D, Patel D, Macnaught G, Czopek A, Bruce L, Donachie J, Gallacher PJ, Tan S, Ahlman M, Grayson PC, Basu N, Dhaun N. 18F-FDG-PET/MR imaging to monitor disease activity in large vessel vasculitis. Nat Commun. 2024 Aug 25;15(1):7314. doi: 10.1038/s41467-024-51613-1.
- Individual participant dataSharing planned: Undecided
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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.
Neeraj Dhaun, MBChB PhD principal investigator
University of Edinburgh
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 Large Vessel Vasculitis, run by University of Edinburgh 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 1 inclusion and 8 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 24 May 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 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?
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?
Maximum standardised uptake values (SUVmax) (time frame: 0 and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03914248, which also lists 1 linked publication.
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 24 May 2022.