PET Imaging of Giant Cell and Takayasu Arteritis

Active, not recruiting

• Conditions: Giant Cell Arteritis; Takayasu Arteritis
• Interventions: Diagnostic Test: PET-MRI

• Registration Number: NCT04071691
• Lead Sponsor: University of Cambridge

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2019-06-25
• Study First Submitted: 2019-08-16
• Study First Submitted QC: 2019-08-25
• Study First Posted: 2019-08-28
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-18
• Last Update Posted: 2024-07-22
• Primary Completion: 2025-04
• Study Completion: 2025-04

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 27

Inclusion Criteria

• Male or female participants >18 years old

• Able to give written, informed consent and to lie flat

• Either:

  1. New clinical diagnosis or acute flare of LVV (Giant-cell arteritis or Takayasu's arteritis) within ~1 week of treatment initiation, and
  2. Clinical indication for 18F-FDG PET-CT scan determined by the referring physician, or
  3. Undergoing surgery for LVV, or
  4. Diagnosis of LVV in remission

Exclusion Criteria

• Women of child bearing potential not using adequate contraception
• Contra-indication to MRI scanning
• Contrast allergy or contrast-nephropathy
• Chronic kidney disease (eGFR <30 mL/min/1.73 m2)
• Any medical condition, in the opinion of the investigator, that prevents the participant from lying flat during scanning, or from participating in the study
• History of recent malignancy deemed relevant to the study by the investigator

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Stable LVV	PET-MRI	Patients with inactive LVV
Active LVV	PET-MRI	Patients with active LVV

Primary Outcome Measures

Name	Time	Method
Diagnostic accuracy of SST2 PET-MRI for LVV	Baseline	To determine the diagnostic accuracy of SST2 PET-MRI for LVV, with the clinically adjudicated diagnosis as the gold-standard.

Secondary Outcome Measures

Name	Time	Method
Comparison with biochemical markers of disease severity	Baseline and 6 months	To compare SST2 PET to C-reactive protein (CRP)
Comparison with clinical measures of disease severity	Baseline and 6 months	To compare SST2 PET to clinical disease activity scores
Treatment response	6 months	To compare vascular SST2 PET pre- and post-treatment for LVV
Active versus inactive disease	Baseline	To compare vascular SST2 PET in patients with active disease versus inactive disease
Comparison of SST2 PET tracers	Baseline and 6 months	To compare 68Ga-DOTATATE PET to 18F-FETO PET

Trial Locations

Locations (2)

University of Cambridge; 🇬🇧 Cambridge, Cambridgeshire, United Kingdom

Imperial College Healthcare NHS Trust; 🇬🇧 London, United Kingdom