PET Imaging of Giant Cell and Takayasu Arteritis (PITA)

July 31, 2022 updated by: Jason Tarkin, University of Cambridge

The PET Imaging of Giant Cell and Takayasu Arteritis Study

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

27

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • London, United Kingdom, W12 0NS
        • Imperial College Healthcare NHS Trust
    • Cambridgeshire
      • Cambridge, Cambridgeshire, United Kingdom, CB2 2QQ
        • University of Cambridge

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with LVV

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Active LVV
Patients with active LVV
Diagnostic test: PET-MRI
SST2 PET-MRI scan
Stable LVV
Patients with inactive LVV
Diagnostic test: PET-MRI
SST2 PET-MRI scan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Cambridge

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 25, 2019

Primary Completion (Anticipated)

August 1, 2023

Study Completion (Anticipated)

August 1, 2023

Study Registration Dates

First Submitted

August 16, 2019

First Submitted That Met QC Criteria

August 25, 2019

First Posted (Actual)

August 28, 2019

Study Record Updates

Last Update Posted (Actual)

August 2, 2022

Last Update Submitted That Met QC Criteria

July 31, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A095007 (PITA)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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