PET Imaging of Giant Cell and Takayasu Arteritis

NCT04071691 | Active Not Recruiting

• 1 other identifier: A095007 (PITA)
• Study Type: observational
• Target: 27
• Locations: 1 country
• Sites: 2

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.

Conditions

Giant Cell Arteritis; Takayasu Arteritis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Treatment response

  6 months

• Active versus inactive disease

  Baseline

• Comparison with biochemical markers of disease severity

  Baseline and 6 months

• Comparison with clinical measures of disease severity

  Baseline and 6 months

• Comparison of SST2 PET tracers

  Baseline and 6 months

Study Arms (2)

Active LVV

Patients with active LVV

Diagnostic Test: PET-MRI

Stable LVV

Patients with inactive LVV

Diagnostic Test: PET-MRI

Interventions

PET-MRI DIAGNOSTIC_TEST

SST2 PET-MRI scan

Active LVV; Stable LVV

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with LVV

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (2)

University of Cambridge

Cambridge, Cambridgeshire, CB2 2QQ, United Kingdom

Location

Imperial College Healthcare NHS Trust

London, W12 0NS, United Kingdom

Location

Related Publications (3)

• 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 68Ga-DOTATATE PET Compared to [18F]FDG PET Imaging. J Am Coll Cardiol. 2017 Apr 11;69(14):1774-1791. doi: 10.1016/j.jacc.2017.01.060.

  PMID: 28385306 BACKGROUND

• Pedersen SF, Sandholt BV, Keller SH, Hansen AE, Clemmensen AE, Sillesen H, Hojgaard L, Ripa RS, Kjaer 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.

  PMID: 25977567 BACKGROUND

• 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.

  PMID: 27173162 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples

MeSH Terms

Conditions

Giant Cell Arteritis; Takayasu Arteritis

Condition Hierarchy (Ancestors)

Vasculitis, Central Nervous System; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Arteritis; Vasculitis; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Aortic Arch Syndromes; Aortic Diseases

Study Officials

• Jason M Tarkin, MBBS PhD

  University of Cambridge

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Wellcome Clinical Research Career Development Fellow

Study Record Dates

• First Submitted: August 16, 2019
• First Posted: August 28, 2019
• Study Start: June 25, 2019
• Primary Completion: April 1, 2025
• Study Completion: April 1, 2025
• Last Updated: July 22, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2)