David against Goliath - Use of microbubbles and more to improve the diagnostics of Giant Cell Arteritis. A pilot study

Giant cell arteritis (GCA) is the most common form of vasculitis and can lead
to serious complications such as acute blindness and ischemic cerebrovascular
accidents (iCVAs). Prompt initiation of corticosteroid treatment can prevent
complications, making prompt diagnosis essential. However, overtreatment must
be avoided, as corticosteroids can cause side effects in > 80% of patients.
Nowadays, ultrasound is increasingly used to make the diagnosis. However, the
sensitivity of the study, the duration of the study (at least 45 minutes),
investigator dependence, and the limited value during follow-up leave room for
improvement. Current techniques that can be added to conventional ultrasound,
used for other conditions, such as contrast enhanced ultrasound sonography
(CEUS), 3D ultrasound (3D) and superb microvascular imaging (SMI) may improve
the current ultrasound of the vessels in GCA with the potential to not only
improve diagnostics, but also the monitoring of GCA activity during follow-up.

The primary aim of this study is to evaluate 3 techniques (CEUS, 3D and SMI),
that can perhaps improve the ultrasound assessment of GCA with regard to its
diagnostic value when applied alone or in combination. The hypothesis is that
the diagnostic value will improve following the addition of the techniques
individually or as a combination. Secondary objectives are to assess the
interobserver variability (as measure of reliability) for the three techniques
alone or in combination in the assessment of GCA. The hypothesis is that these
can also be improved. For 3D ultrasound, the time reduction compared to
conventional ultrasound will be assessed, as a time reduction is only expected
for this technique.

This study is a cross-sectional pilotstudy

The techniques that will be tested in this study can potentially contribute to
improving the diagnostic value of ultrasound in GCA. A better diagnostic value
allows for rapid and accurate treatment, reducing the risk of irreversible
complications of GCA itself or of overtreatment using corticosteroids. Two of
the techniques (3D and SMI) are add-ons to the ultrasound machine and pose no
additional risks for patients. The third technique, CEUS, has a small risk
(0.125%) of reversible side effects such as headache and nausea, and a very
small risk (0.0086%) of an allergic reaction. The drug that will be used for
CEUS, Sonovue, has been extensively researched and is used in regular care for
ultrasound in cardiology. The risk for study participants is therefore minimal.
The contribution to the study will not bring any personal benefit to the
participants. They will contribute to the study for around 3 hours and receive
an injection for the administration of Sonovue. Disease data will also be
collected from participating patients.
In this pilot study, the 3 techniques will be tested seperately and
simultaneously. The data from this study will show which (combination of)
techniques are best suited for further research with regards to improving
diagnosis and follow-up in patients with GCA.