PET Imaging of Giant Cell and Takayasu Arteritis (PITA)

University of Cambridge

Status

Active, not recruiting

Conditions

Giant Cell Arteritis

Takayasu Arteritis

Treatments

Diagnostic Test: PET-MRI

Study type

Observational

Funder types

Other

Identifiers

NCT04071691

A095007 (PITA)

Details and patient eligibility

About

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.

Full 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.

Enrollment

27 patients

Sex

All

Ages

18 to 99 years old

Volunteers

No Healthy Volunteers

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