PET Imaging of Giant Cell and Takayasu Arteritis

Giant Cell Arteritis Clinical Trial

— PITA  

Official title:

The PET Imaging of Giant Cell and Takayasu Arteritis Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04071691
• Other study ID #: A095007 (PITA)
• Status: Active, not recruiting
• Start date: June 25, 2019
• Est. completion date: August 2023

Study information

• Verified date: July 2022
• Source: University of Cambridge
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 27
• Est. completion date: August 2023
• Est. primary completion date: August 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Arteritis
• Giant Cell Arteritis
• Polymyalgia Rheumatica
• Takayasu Arteritis

Intervention

Diagnostic Test:
• PET-MRI
SST2 PET-MRI scan

Locations

Country	Name	City	State
United Kingdom	University of Cambridge	Cambridge	Cambridgeshire
United Kingdom	Imperial College Healthcare NHS Trust	London

Sponsors (5)

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

Country where clinical trial is conducted

United Kingdom, 

References & Publications (3)

Dubash SR, Keat N, Mapelli P, Twyman F, Carroll L, Kozlowski K, Al-Nahhas A, Saleem A, Huiban M, Janisch R, Frilling A, Sharma R, Aboagye EO. Clinical Translation of a Click-Labeled 18F-Octreotate Radioligand for Imaging Neuroendocrine Tumors. J Nucl Med. 2016 Aug;57(8):1207-13. doi: 10.2967/jnumed.115.169532. Epub 2016 May 12. — View Citation

Pedersen SF, Sandholt BV, Keller SH, Hansen AE, Clemmensen AE, Sillesen H, Højgaard L, Ripa RS, Kjær A. 64Cu-DOTATATE PET/MRI for Detection of Activated Macrophages in Carotid Atherosclerotic Plaques: Studies in Patients Undergoing Endarterectomy. Arterioscler Thromb Vasc Biol. 2015 Jul;35(7):1696-703. doi: 10.1161/ATVBAHA.114.305067. Epub 2015 May 14. — View Citation

Tarkin JM, Joshi FR, Evans NR, Chowdhury MM, Figg NL, Shah AV, Starks LT, Martin-Garrido A, Manavaki R, Yu E, Kuc RE, Grassi L, Kreuzhuber R, Kostadima MA, Frontini M, Kirkpatrick PJ, Coughlin PA, Gopalan D, Fryer TD, Buscombe JR, Groves AM, Ouwehand WH, Bennett MR, Warburton EA, Davenport AP, Rudd JH. Detection of Atherosclerotic Inflammation by (68)Ga-DOTATATE PET Compared to [(18)F]FDG PET Imaging. J Am Coll Cardiol. 2017 Apr 11;69(14):1774-1791. doi: 10.1016/j.jacc.2017.01.060. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic accuracy of SST2 PET-MRI for LVV	To determine the diagnostic accuracy of SST2 PET-MRI for LVV, with the clinically adjudicated diagnosis as the gold-standard.	Baseline
Secondary	Treatment response	To compare vascular SST2 PET pre- and post-treatment for LVV	6 months
Secondary	Active versus inactive disease	To compare vascular SST2 PET in patients with active disease versus inactive disease	Baseline
Secondary	Comparison with biochemical markers of disease severity	To compare SST2 PET to C-reactive protein (CRP)	Baseline and 6 months
Secondary	Comparison with clinical measures of disease severity	To compare SST2 PET to clinical disease activity scores	Baseline and 6 months
Secondary	Comparison of SST2 PET tracers	To compare 68Ga-DOTATATE PET to 18F-FETO PET	Baseline and 6 months