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Giant Cell ArteritisNCT04204876

Longitudinal Imaging in Patients With Large Vessel Vasculitis to Predict Further Disease Course

An observational study of Giant Cell Arteritis and Large Vessel Giant Cell Arteriitis, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Longitudinal imaging in patients with large vessel vasculitis to predict further disease course Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Magnet Resonance Imaging (MRI) and PET/CT analysis
How many people
40 participants
Where
1 siteSwitzerland
Study dates
28 May 2020to 5 Aug 2023
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: All patients presenting with a new diagnosis of LV-GCA and all patients already treated for LV-GCA and planned for treatment termination at the University Hospital Basel.

Who may be able to join

  • Confirmed diagnosis of GCA and having a diagnosis of LV-GCA confirmed by imaging (PET/CT)
  • Informed consent to the local GCA cohort BARK
  • Followed for GCA treatment in the outpatient department.

Who cannot join

  • Known hypersensitivity or allergy to Gadolinium (Gd)-based MRI contrast agents.
  • Patients with cardiac pacemakers, intra cranial clips, metallic foreign bodies or other not MR-compatible implants (e.g. pumps etc.).
  • Renal failure or severely impaired kidney function (eGFR < 30 ml/min /1,73 m2)
  • Epilepsy.

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

  • Department of Rheumatology, University Hospital Basel

    Basel, 4031

Other trials in Switzerland

About this study

Longitudinal imaging in patients with large vessel vasculitis to predict further disease course

Read the detailed description

This explorative longitudinal prospective observational study is to explore different aspects of vessel wall characteristics as detected by magnet resonance imaging (MRI) techniques and positron emission tomography/computer tomography (PET/CT) in patients with large vessel giant cell Arteriitis (LV-GCA) for their usefulness as predictive factor for future giant cell arteritis (GCA) relapse. It analyses parameters in PET/CT and MRI in patients with GCA at treatment stop which correlate with GCA relapse within the first 6 months after treatment stop.

Patients included in the established local GCA database (BARK) will be screened for eligibility. Aortal imaging is performed during routine care according to established guidelines at diagnosis and during Follow Up at least every two years and before treatment stop.

Being tested
Magnet Resonance Imaging (MRI), PET/CT analysis
Keywords
magnet resonance imaging (MRI), Positron emission tomography/computer tomography (PET/CT), GCA relapse
Medical subject headings
Giant Cell Arteritis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Magnet Resonance Imaging (MRI)Diagnostic test

    MRI with and without Gadolinium contrast agent for the following vessels: thoracic aorta (ascending, arch, descending arch, left and right common carotic, subclavian, and vertebral artery)

  • PET/CT analysisDiagnostic test

    Standard value uptake measurement (SUV) based on quantitative score normalized to liver (SUV vessel max/liver mean) at the following vessel regions: Carotid artery: common, internal, external; Subclavian artery; Axillary artery; Vertebral artery; Thoracic Aorta; Abdominal Aorta; Common femoral artery; Deep femoral artery; Popliteal artery

Study groups in NCT04204876
Study groupRoleWhat they receive
patients with GCAAll patients presenting with a new diagnosis of LV-GCA and all patients already treated for LV-GCA and planned for treatment termination
Receives: Diagnostic Test: Magnet Resonance Imaging (MRI); Diagnostic Test: PET/CT analysis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in mural thickening at MRI analysis

    0 = no mural thickening (maximal vessel wall thickness <2 mm for aorta, <1mm for its branches)

    1. = mural thickening (2-3 mm for aorta, 1-2 mm for its branches);
    2. = strong thickening (>3 mm for aorta, >2mm for its branches)

    Measured: at time of diagnosis of GCA and before treatment stop (in order 52 weeks after treatment start)

Secondary outcomes (5)

  1. Change in late mural enhancement (subjective grading) at MRI analysis

    0= no mural enhancement;

    1. slight mural enhancement;
    2. strong mural enhancement and/or perivascular enhancement

    Measured: at time of diagnosis of GCA and before treatment stop (in order 52 weeks after treatment start)

  2. Change in mural edema (subjective grading) at MRI analysis

    0= no mural edema;

    1. slight mural edema;
    2. strong mural edema

    Measured: at time of diagnosis of GCA and before treatment stop (in order 52 weeks after treatment start)

  3. Change in dynamic contrast agent uptake in Golden Angle Radial Sparse Parallel MRI (GRASP MRI)

    Dynamic contrast agent uptake in GRASP will be assessed in areas with wall thickening (grade 1 or 2 as defined above)

    Measured: at time of diagnosis of GCA and before treatment stop (in order 52 weeks after treatment start)

  4. Change in Apparent Diffusion Coefficient (ADC) as assessed with DW-MRI in absolute numbers (in mm2/s)

    Apparent Diffusion Coefficient (ADC) as assessed with DW-MRI in absolute numbers (in mm2/s)

    Measured: at time of diagnosis of GCA and before treatment stop (in order 52 weeks after treatment start)

  5. Change in Standard value uptake measurement (SUV) based on quantitative score normalized to liver (SUV vessel max/liver mean) at PET/CT analysis

    Standard value uptake measurement (SUV) based on quantitative score normalized to liver (SUV vessel max/liver mean)

    Measured: at time of diagnosis of GCA and before treatment stop (in order 52 weeks after treatment start)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Dec 2019
  2. Study start28 May 2020
  3. Primary completion5 Aug 2023
  4. Study completion5 Aug 2023

Resources

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
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04204876
Sponsor's protocol ID
2019-02161; me18Daikeler
Other IDs
2019
Status last verified
Jan 2024
First submitted
17 Dec 2019
Last updated
18 Jan 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Stone JH, Tuckwell K, Dimonaco S, Klearman M, Aringer M, Blockmans D, Brouwer E, Cid MC, Dasgupta B, Rech J, Salvarani C, Schett G, Schulze-Koops H, Spiera R, Unizony SH, Collinson N. Trial of Tocilizumab in Giant-Cell Arteritis. N Engl J Med. 2017 Jul 27;377(4):317-328. doi: 10.1056/NEJMoa1613849.

    PubMed 28745999

  • Restuccia G, Boiardi L, Cavazza A, Catanoso M, Macchioni P, Muratore F, Cimino L, Aldigeri R, Crescentini F, Pipitone N, Salvarani C. Flares in Biopsy-Proven Giant Cell Arteritis in Northern Italy: Characteristics and Predictors in a Long-Term Follow-Up Study. Medicine (Baltimore). 2016 May;95(19):e3524. doi: 10.1097/MD.0000000000003524.

    PubMed 27175649

  • Kermani TA, Sreih AG, Cuthbertson D, Carette S, Hoffman GS, Khalidi NA, Koening CL, Langford CA, McAlear CA, Monach PA, Moreland L, Pagnoux C, Seo P, Warrington KJ, Ytterberg SR, Merkel PA; Vasculitis Clinical Research Consortium. Evaluation of damage in giant cell arteritis. Rheumatology (Oxford). 2018 Feb 1;57(2):322-328. doi: 10.1093/rheumatology/kex397.

    PubMed 29112740

  • Quinn KA, Ahlman MA, Malayeri AA, Marko J, Civelek AC, Rosenblum JS, Bagheri AA, Merkel PA, Novakovich E, Grayson PC. Comparison of magnetic resonance angiography and 18F-fluorodeoxyglucose positron emission tomography in large-vessel vasculitis. Ann Rheum Dis. 2018 Aug;77(8):1165-1171. doi: 10.1136/annrheumdis-2018-213102. Epub 2018 Apr 17.

    PubMed 29666047

  • Dejaco C, Ramiro S, Duftner C, Besson FL, Bley TA, Blockmans D, Brouwer E, Cimmino MA, Clark E, Dasgupta B, Diamantopoulos AP, Direskeneli H, Iagnocco A, Klink T, Neill L, Ponte C, Salvarani C, Slart RHJA, Whitlock M, Schmidt WA. EULAR recommendations for the use of imaging in large vessel vasculitis in clinical practice. Ann Rheum Dis. 2018 May;77(5):636-643. doi: 10.1136/annrheumdis-2017-212649. Epub 2018 Jan 22.

    PubMed 29358285

  • Attenberger UI, Liu J, Riffel P, Budjan J, Grimm R, Block KT, Schoenberg SO, Wang X, Hausmann D. Quantitative Perfusion Analysis of the Rectum Using Golden-Angle Radial Sparse Parallel Magnetic Resonance Imaging: Initial Experience and Comparison to Time-Resolved Angiography With Interleaved Stochastic Trajectories. Invest Radiol. 2017 Dec;52(12):715-724. doi: 10.1097/RLI.0000000000000397.

    PubMed 28622248

  • Riffel P, Zoellner FG, Budjan J, Grimm R, Block TK, Schoenberg SO, Hausmann D. "One-Stop Shop": Free-Breathing Dynamic Contrast-Enhanced Magnetic Resonance Imaging of the Kidney Using Iterative Reconstruction and Continuous Golden-Angle Radial Sampling. Invest Radiol. 2016 Nov;51(11):714-719. doi: 10.1097/RLI.0000000000000299.

    PubMed 27299581

  • Parikh N, Ream JM, Zhang HC, Block KT, Chandarana H, Rosenkrantz AB. Performance of simultaneous high temporal resolution quantitative perfusion imaging of bladder tumors and conventional multi-phase urography using a novel free-breathing continuously acquired radial compressed-sensing MRI sequence. Magn Reson Imaging. 2016 Jun;34(5):694-8. doi: 10.1016/j.mri.2015.12.033. Epub 2015 Dec 29.

    PubMed 26740058

  • Rosenkrantz AB, Geppert C, Grimm R, Block TK, Glielmi C, Feng L, Otazo R, Ream JM, Romolo MM, Taneja SS, Sodickson DK, Chandarana H. Dynamic contrast-enhanced MRI of the prostate with high spatiotemporal resolution using compressed sensing, parallel imaging, and continuous golden-angle radial sampling: preliminary experience. J Magn Reson Imaging. 2015 May;41(5):1365-73. doi: 10.1002/jmri.24661. Epub 2014 May 16.

    PubMed 24833417

  • Reichenbach S, Adler S, Bonel H, Cullmann JL, Kuchen S, Butikofer L, Seitz M, Villiger PM. Magnetic resonance angiography in giant cell arteritis: results of a randomized controlled trial of tocilizumab in giant cell arteritis. Rheumatology (Oxford). 2018 Jun 1;57(6):982-986. doi: 10.1093/rheumatology/key015.

    PubMed 29529280

  • Blockmans D, de Ceuninck L, Vanderschueren S, Knockaert D, Mortelmans L, Bobbaers H. Repetitive 18F-fluorodeoxyglucose positron emission tomography in giant cell arteritis: a prospective study of 35 patients. Arthritis Rheum. 2006 Feb 15;55(1):131-7. doi: 10.1002/art.21699.

    PubMed 16463425

  • Martinez-Rodriguez I, Jimenez-Alonso M, Quirce R, Jimenez-Bonilla J, Martinez-Amador N, De Arcocha-Torres M, Loricera J, Blanco R, Gonzalez-Gay MA, Banzo I. 18F-FDG PET/CT in the follow-up of large-vessel vasculitis: A study of 37 consecutive patients. Semin Arthritis Rheum. 2018 Feb;47(4):530-537. doi: 10.1016/j.semarthrit.2017.08.009. Epub 2017 Aug 31.

    PubMed 28967430

  • Grayson PC, Alehashemi S, Bagheri AA, Civelek AC, Cupps TR, Kaplan MJ, Malayeri AA, Merkel PA, Novakovich E, Bluemke DA, Ahlman MA. 18 F-Fluorodeoxyglucose-Positron Emission Tomography As an Imaging Biomarker in a Prospective, Longitudinal Cohort of Patients With Large Vessel Vasculitis. Arthritis Rheumatol. 2018 Mar;70(3):439-449. doi: 10.1002/art.40379. Epub 2018 Feb 6.

    PubMed 29145713

  • Imfeld S, Rottenburger C, Schegk E, Aschwanden M, Juengling F, Staub D, Recher M, Kyburz D, Berger CT, Daikeler T. [18F]FDG positron emission tomography in patients presenting with suspicion of giant cell arteritis-lessons from a vasculitis clinic. Eur Heart J Cardiovasc Imaging. 2018 Aug 1;19(8):933-940. doi: 10.1093/ehjci/jex259.

    PubMed 29126277

  • Ironi G, Tombetti E, Napolitano A, Campolongo M, Fallanca F, Incerti E, Picchio M, Dagna L, Manfredi AA, Gianolli L, Del Maschio A, De Cobelli F. Diffusion-Weighted Magnetic Resonance Imaging Detects Vessel Wall Inflammation in Patients With Giant Cell Arteritis. JACC Cardiovasc Imaging. 2018 Dec;11(12):1879-1882. doi: 10.1016/j.jcmg.2018.06.015. Epub 2018 Aug 15. No abstract available.

    PubMed 30121275

Questions about this trial

What is this clinical trial studying?

An observational study of Giant Cell Arteritis and Large Vessel Giant Cell Arteriitis, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.

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 4 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 18 Jan 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 Switzerland. 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?

Change in mural thickening at MRI analysis (time frame: at time of diagnosis of GCA and before treatment stop (in order 52 weeks after treatment start)). 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 NCT04204876, which also lists 15 linked publications.

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 18 Jan 2024.

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