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NCT Number: NCT04071691

PET Imaging of Giant Cell and Takayasu Arteritis

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female participants >18 years old
  • Able to give written, informed consent and to lie flat
  • Either:
  • New clinical diagnosis or acute flare of LVV (Giant-cell arteritis or Takayasu's arteritis) within ~1 week of treatment initiation, and
  • Clinical indication for 18F-FDG PET-CT scan determined by the referring physician, or
  • Undergoing surgery for LVV, or
  • 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

Treatment and study plan

PET-MRI

Diagnostic Test

SST2 PET-MRI scan

Primary outcomes

  1. Diagnostic accuracy of SST2 PET-MRI for LVV

    Time frame: Baseline

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

Secondary outcomes

  1. Treatment response

    Time frame: 6 months

    To compare vascular SST2 PET pre- and post-treatment for LVV

  2. Active versus inactive disease

    Time frame: Baseline

    To compare vascular SST2 PET in patients with active disease versus inactive disease

  3. Comparison with biochemical markers of disease severity

    Time frame: Baseline and 6 months

    To compare SST2 PET to C-reactive protein (CRP)

  4. Comparison with clinical measures of disease severity

    Time frame: Baseline and 6 months

    To compare SST2 PET to clinical disease activity scores

  5. Comparison of SST2 PET tracers

    Time frame: Baseline and 6 months

    To compare 68Ga-DOTATATE PET to 18F-FETO PET

Sponsors and collaborators

Lead sponsor

University of Cambridge

Other

Collaborators

  • Cambridge University Hospitals NHS Foundation Trust
  • Imperial College London
  • National Institute for Health Research, United Kingdom
  • Wellcome Trust

Registry information

Official study title

The PET Imaging of Giant Cell and Takayasu Arteritis Study

Acronym: PITA

Important dates

Study start
2019
Primary completion
2025
Study completion
2025
First posted
Aug 28, 2019
Registry last updated
Jul 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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