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PET Imaging of Giant Cell and Takayasu Arteritis (PITA)

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ClinicalTrials.gov Identifier: NCT04071691
Recruitment Status : Recruiting
First Posted : August 28, 2019
Last Update Posted : August 29, 2019
Sponsor:
Collaborators:
Cambridge University Hospitals NHS Foundation Trust
Wellcome Trust
Imperial College London
National Institute for Health Research, United Kingdom
Information provided by (Responsible Party):
Jason Tarkin, 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.

Condition or disease Intervention/treatment
Giant Cell Arteritis Takayasu Arteritis Diagnostic Test: PET-MRI

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.

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Study Type : Observational
Estimated Enrollment : 25 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The PET Imaging of Giant Cell and Takayasu Arteritis Study
Actual Study Start Date : June 25, 2019
Estimated Primary Completion Date : August 2023
Estimated Study Completion Date : August 2023


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




Primary Outcome Measures :
  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 Outcome Measures :
  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


Biospecimen Retention:   Samples With DNA
Blood samples


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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with LVV
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04071691


Contacts
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Contact: Jason M Tarkin, MBBS PhD +44(0)1223331504 jt545@cam.ac.uk

Locations
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United Kingdom
University of Cambridge Recruiting
Cambridge, Cambridgeshire, United Kingdom, CB2 2QQ
Contact: Jason M Tarkin, MBBS PhD       jt545@cam.ac.uk   
Sub-Investigator: James HF Rudd, MD PhD         
Sub-Investigator: James Peters, MD PhD         
Imperial College Healthcare NHS Trust Not yet recruiting
London, United Kingdom, W12 0NS
Contact: Jason M Tarkin, MBBS PhD         
Contact       jt545@cam.ac.uk   
Sub-Investigator: Justin C Mason, MD PhD         
Sponsors and Collaborators
University of Cambridge
Cambridge University Hospitals NHS Foundation Trust
Wellcome Trust
Imperial College London
National Institute for Health Research, United Kingdom
Investigators
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Principal Investigator: Jason M Tarkin, MBBS PhD University of Cambridge

Publications:
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Responsible Party: Jason Tarkin, Wellcome Clinical Research Career Development Fellow, University of Cambridge
ClinicalTrials.gov Identifier: NCT04071691     History of Changes
Other Study ID Numbers: A095007 (PITA)
First Posted: August 28, 2019    Key Record Dates
Last Update Posted: August 29, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Vasculitis
Vasculitis, Central Nervous System
Polymyalgia Rheumatica
Giant Cell Arteritis
Arteritis
Takayasu Arteritis
Aortic Arch Syndromes
Vascular Diseases
Cardiovascular Diseases
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Skin Diseases, Vascular
Skin Diseases
Autoimmune Diseases
Immune System Diseases
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Aortic Diseases