Clinical trial: Use of Gallium-68 HA-DOTATATE PET/CT in Giant Cell Arteritis (GCA) (NCT03812302)

Eligibility criteria:
Inclusion Criteria:

        Participants must:

          1. Meet the revised GCA diagnosis criteria (modified from ref 1)

          2. Have either newly-diagnosed or relapsing disease

          3. Have active disease (modified from ref 1, to remove ESR/CRP requirements)

          4. Have been empirically started on glucocorticoid treatment (or had baseline
             glucocorticoid dose increased, in the case of relapsers) ≤ 2 weeks of enrolment

          5. 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).

          1. Age ≥ 50 years

          2. And at least 1 of a. or b. :

               1. Unequivocal cranial symptoms of GCA (new headache, scalp or temporal artery
                  tenderness, ischemia-related vision loss, jaw/mouth claudication

               2. Unequivocal symptoms of polymyalgia rheumatica (PMR), defined as shoulder and/or
                  hip girdle pain associated with inflammatory stiffness

          3. And at least 1 of a. or b.:

               1. Temporal artery biopsy revealing features of GCA

               2. 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.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 50 Years old.


Patient description (medical language): A 61-year-old man comes to the emergency department complaining of an acute vision disturbance. He had an episode of vision disturbance in the right eye that occurred suddenly and resolved spontaneously in 15 minutes. He also has right jaw pain while chewing.  He also complains of fatigue and hip muscle aches over the last several months.  The patient has a history of mild hyperlipidemia that has been controlled by diet and lifestyle modifications.  On examination, his blood pressure is 130/70 mm Hg and pulse is 66/min.  Neurological examination is unremarkable.  Visual examination is also normal. ESR is 103 mm/h. Temporal artery biopsy shows multinuclear giant cells and internal elastic membrane fragmentation.

Patient description (patient's own words): I’m a 61-year-old man and I came to the ER because I had a sudden episode where I couldn’t see out of my right eye. It only lasted about 15 minutes and went away on its own but it really scared me. I’ve also been having pain in my right jaw when I chew. For the past few months I’ve felt really tired and noticed my hips ache a lot. I have a history of mild cholesterol issues but I’ve been managing that with my diet and lifestyle. When the doctors checked me my blood pressure and pulse were normal and my vision and neurological exams didn’t show anything wrong. However they ran some tests and said my ESR levels were very high and a biopsy of my temporal artery showed some inflammation and damage.

Does the patient match the trial criteria? Entailment