PET-MRI
Diagnostic TestSST2 PET-MRI scan
NCT Number: NCT04071691
While 18F-fluorodeoxyglucose (FDG) positron emission tomography (PET) imaging is often included in the diagnostic work-up of patients with large-vessel vasculitis (LVV), 18F-FDG lacks specificity for inflammatory cells and has limited ability to track therapy response. Moreover, high background 18F-FDG uptake in the brain and myocardium largely precludes imaging temporal arteritis in giant-cell arteritis (GCA) and coronary artery involvement in Takayasu arteritis respectively. These limitations of 18F-FDG for imaging LVV highlight important unmet clinical needs, which might be overcome by using a somatostatin receptor subtype-2 (SST2) PET tracer.
This study is active but is not currently recruiting participants.
Notify Me18 year–99 year
All sexes
Observational
University of Cambridge, Cambridge, Cambridgeshire, United Kingdom
Up-regulation of SST2 in activated macrophages represents a novel imaging target for measuring vascular inflammation, which has been previously examined in atherosclerosis using 68Ga-DOTATATE. To test the hypothesis that SST2 PET imaging can accurately identify LVV, patients with active GCA or Takayasu arteritis will undergo vascular 68Ga-DOTATATE or 18F-fluoroethyltriazole-(Tyr3)-octreotate (FETO) PET-MRI at baseline, with repeat imaging after 6 months of treatment. A group of individuals with LVV in clinical remission will also undergo SST2 PET imaging. Data from patients with clinically inactive disease will serve to confirm tracer specificity for active disease, as well as signal reproducibility. 18F-FETO is an alternative SST2 tracer to 68Ga-DOTATATE; the longer half-life and shorter positron range of 18F compared to 68Ga may offer several advantages, including wider tracer availability and improved spatial resolution when imaging small arteries. All patients will also undergo 18F-FDG imaging before treatment, where clinically indicated.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
SST2 PET-MRI scan
Time frame: Baseline
To determine the diagnostic accuracy of SST2 PET-MRI for LVV, with the clinically adjudicated diagnosis as the gold-standard.
Time frame: 6 months
To compare vascular SST2 PET pre- and post-treatment for LVV
Time frame: Baseline
To compare vascular SST2 PET in patients with active disease versus inactive disease
Time frame: Baseline and 6 months
To compare SST2 PET to C-reactive protein (CRP)
Time frame: Baseline and 6 months
To compare SST2 PET to clinical disease activity scores
Time frame: Baseline and 6 months
To compare 68Ga-DOTATATE PET to 18F-FETO PET
University of Cambridge
Other
The PET Imaging of Giant Cell and Takayasu Arteritis Study
Acronym: PITA
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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