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

January 17, 2024 updated by: University Hospital, Basel, Switzerland
Longitudinal imaging in patients with large vessel vasculitis to predict further disease course

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Switzerland
      • Basel, Switzerland, 4031
        • Department of Rheumatology, University Hospital Basel

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

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.

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
patients with GCA
All patients presenting with a new diagnosis of LV-GCA and all patients already treated for LV-GCA and planned for treatment termination
Diagnostic test: Magnet Resonance Imaging (MRI)
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)
Diagnostic test: PET/CT analysis
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in late mural enhancement (subjective grading) at MRI analysis
Time Frame: at time of diagnosis of GCA and before treatment stop (in order 52 weeks after treatment start)

0= no mural enhancement;

  1. slight mural enhancement;
  2. strong mural enhancement and/or perivascular enhancement
at time of diagnosis of GCA and before treatment stop (in order 52 weeks after treatment start)
Change in mural edema (subjective grading) at MRI analysis
Time Frame: at time of diagnosis of GCA and before treatment stop (in order 52 weeks after treatment start)

0= no mural edema;

  1. slight mural edema;
  2. strong mural edema
at time of diagnosis of GCA and before treatment stop (in order 52 weeks after treatment start)
Change in dynamic contrast agent uptake in Golden Angle Radial Sparse Parallel MRI (GRASP MRI)
Time Frame: at time of diagnosis of GCA and before treatment stop (in order 52 weeks after treatment start)
Dynamic contrast agent uptake in GRASP will be assessed in areas with wall thickening (grade 1 or 2 as defined above)
at time of diagnosis of GCA and before treatment stop (in order 52 weeks after treatment start)
Change in Apparent Diffusion Coefficient (ADC) as assessed with DW-MRI in absolute numbers (in mm2/s)
Time Frame: at time of diagnosis of GCA and before treatment stop (in order 52 weeks after treatment start)
Apparent Diffusion Coefficient (ADC) as assessed with DW-MRI in absolute numbers (in mm2/s)
at time of diagnosis of GCA and before treatment stop (in order 52 weeks after treatment start)
Change in Standard value uptake measurement (SUV) based on quantitative score normalized to liver (SUV vessel max/liver mean) at PET/CT analysis
Time Frame: at time of diagnosis of GCA and before treatment stop (in order 52 weeks after treatment start)
Standard value uptake measurement (SUV) based on quantitative score normalized to liver (SUV vessel max/liver mean)
at time of diagnosis of GCA and before treatment stop (in order 52 weeks after treatment start)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Basel, Switzerland

Collaborators

Swiss Foundation for the Study of Muscular Diseases

Investigators

  • Principal Investigator: Thomas Daikeler, Prof. Dr. MD, Department of Rheumatology, University Hospital Basel

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 28, 2020

Primary Completion (Actual)

August 5, 2023

Study Completion (Actual)

August 5, 2023

Study Registration Dates

First Submitted

December 17, 2019

First Submitted That Met QC Criteria

December 17, 2019

First Posted (Actual)

December 19, 2019

Study Record Updates

Last Update Posted (Actual)

January 18, 2024

Last Update Submitted That Met QC Criteria

January 17, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019-02161; me18Daikeler

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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