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Completed

NCT Number: NCT03812302

Use of Gallium-68 HA-DOTATATE PET/CT in Giant Cell Arteritis (GCA)

The aim of this study is to compare the use of FDG PET/CT to Ga-68 HA-DOTATATE (abbreviated DOTATATE) PET/CT in patients with active giant cell arteritis (GCA) started on prednisone to understand if DOTATATE can identify more areas of active blood vessel inflammation than FDG.

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Key information

Conditions

Giant Cell Arteritis Arteritis Autoimmune Diseases Autoimmune Diseases of the Nervous System Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Immune System Diseases Nervous System Diseases Skin Diseases Skin Diseases, Vascular Skin and Connective Tissue Diseases Vascular Diseases Vasculitis Vasculitis, Central Nervous System

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Alberta

Edmonton, Alberta, T6G 2G3, Canada

About this study

The aim of this study is to prospectively evaluate the potential use of 68-Ga HA-DOTATATE PET/CT for detecting medium-large vessel inflammation in a small number of GCA patients with active disease, as compared to FDG PET/CT, and to understand if DOTATATE uptake correlates with disease activity. Fifteen patients with active GCA (either newly-diagnosed or recently relapsed disease) who are receiving glucocorticoids will be enrolled. Participants will undergo baseline FDG PET/CT and baseline DOTATATE PET/CT scan. Tracer uptake will be described in 8 major vascular territories. DOTATATE PET/CT will be repeated again in 6 months, and tracer uptake will be correlated to clinical disease activity, and medication use.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Participants must:

  • Meet the revised GCA diagnosis criteria (modified from ref 1)
  • Have either newly-diagnosed or relapsing disease
  • Have active disease (modified from ref 1, to remove ESR/CRP requirements)
  • Have been empirically started on glucocorticoid treatment (or had baseline glucocorticoid dose increased, in the case of relapsers) ≤ 2 weeks of enrolment
  • Participant must be have had (or will be willing to undergo) an urgent FDG-PET/CT as part of routine clinical care.

GCA diagnosis criteria (modified from ref 1, to remove ESR requirement).

  • Age ≥ 50 years
  • And at least 1 of a. or b. :
  • Unequivocal cranial symptoms of GCA (new headache, scalp or temporal artery tenderness, ischemia-related vision loss, jaw/mouth claudication
  • Unequivocal symptoms of polymyalgia rheumatica (PMR), defined as shoulder and/or hip girdle pain associated with inflammatory stiffness
  • And at least 1 of a. or b.:
  • Temporal artery biopsy revealing features of GCA
  • Evidence of large-vessel vasculitis by angiography or cross-sectional imaging study such as magnetic resonance angiography (MRA), computed tomography angiography (CTA), or positron emission tomography-computed tomography (PET-CT)

Exclusion criteria

  • Patients not meeting the above criteria or who are unable to provide informed consent will be excluded.

Treatment and study plan

68-Ga HA-DOTATATE PET/CT

Diagnostic Test

See arm description.

Primary outcomes

  1. Comparison of FDG vs DOTATATE vascular uptake in individual vascular territories using target-blood pool ratios (TBR)

    Time frame: time 0 (baseline)

Secondary outcomes

  1. Qualitative comparison of FDG vs DOTATATE vascular uptake in individual vascular (scores 0-3) territories using visual uptake scores

    Time frame: time 0 (baseline)

  2. Changes in vascular DOTATATE uptake scores over time (quantitatively and qualitatively)

    Time frame: 6 months

  3. Correlation between vascular DOTATATE uptake scores and clinical status

    Time frame: 0 and 6 months

  4. Correlation between vascular DOTATATE uptake scores and cumulative glucocorticoid exposure

    Time frame: 0 and 6 months

Sponsors and collaborators

Lead sponsor

University of Alberta

Other

Registry information

Official study title

Evaluating the Use of Gallium-68 HA-DOTATATE Positron Emission Tomography/Computerized Tomography (PET/CT) in Patients With Giant Cell Arteritis (GCA.)

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Jan 23, 2019
Registry last updated
Oct 18, 2023

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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