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

  • STATUS
    Recruiting
  • End date
    Feb 27, 2023
  • participants needed
    15
  • sponsor
    University of Alberta
Updated on 27 April 2022
angiography
magnetic resonance angiography
prednisone
MRI
headache
positron emission tomography
dotatate
vasculitis
blindness
stiffness
intermittent claudication
positron emission tomography/computed tomography
polymyalgia
artery biopsy
temporal artery biopsy
fdg pet/ct

Summary

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.

Description

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.

Details
Condition Giant Cell Arteritis
Treatment 68-Ga HA-DOTATATE PET/CT
Clinical Study IdentifierNCT03812302
SponsorUniversity of Alberta
Last Modified on27 April 2022

Eligibility

Yes No Not Sure

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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

0/250

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note