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FDG Uptake in Large-Vessel Giant Cell Arteritis After Short-term, High-Dose Steroid Treatment

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ClinicalTrials.gov Identifier: NCT03285945
Recruitment Status : Completed
First Posted : September 18, 2017
Last Update Posted : September 18, 2017
Sponsor:
Information provided by (Responsible Party):
University of Aarhus

Brief Summary:

Giant cell arteritis (GCA) affects large and medium sized vessels. Large vessel-GCA (LV-GCA) affecting aorta and/or its main branches is seen a) together with temporal arteritis (AT-GCA), b) as isolated LV-GCA but also c) with polymyalgia rheumatica.

There is a risk of vision loss and cerebral thromboembolic events or great vessel injury in GCA. With delayed or inadequate treatment mortality and morbidity increases. This highlights the need of fast diagnosis and early treatment.

The cornerstone in the diagnosis of GCA is a positive temporal artery biopsy. Patients with LV-GCA have more general, but less cephalic symptoms than patients with AT-GCA. Also, biopsy from large vessels can rarely be done and only 50% have a positive temporal artery biopsy (TAB). Hence, diagnosis often rely on imaging.

Fluorine-18-fluorodeoxyglucose positron-emission tomography (FDG PET)/CT has shown high diagnostic sensitivity and specificity and is believed to be superior to other imaging modalities in the diagnosis of LV-GCA . The impact of FDG PET/CT in the management of LV-GCA has been evaluated and has shown to increase the diagnostic accuracy in a significant proportion of patients. However, studies have indicated a lower sensitivity in steroid treated patients.

The aim of this study, was to evaluate the effect of steroid treatment on large-vessel FDG uptake in new-onset, treatment-naive LV-GCA by repetitive FDG PET/CT pre- and post therapeutic. With insights into the diagnostic capabilities after treatment is initiated, the possibility of timely treatment and confident diagnostic work up will improve.


Condition or disease Intervention/treatment
Giant Cell Arteritis Drug: PET3 Drug: PET10

Detailed Description:

As standard of care, patients suspected of GCA undergo clinical examination, laboratory screening, temporal artery biopsy, vascular ultrasound examination and FDG PET/CT.

All patients with a diagnosis of GCA will be treated with 60 mg af prednisolone and tapered according to a predefined algorithm.

In patients with FDG PET/CT verified LV-GCA, FDG PET/CT is repeated after either 3 (n=12) or 10 (n=12) days of steroid treatment.

An experienced nuclear medicine physician (LCG), blinded to clinical symptoms and findings, qualitatively assesses PET scans. A semiquantitative approach is applied (a.m. Meller) in which FDG uptake in vascular regions is graded on a 5-point scale (0 = no uptake, 1 = uptake below or equal to blood pool, 2 = above blood pool but below liver, 3 = above liver, 4 = 2 times above liver). Any score ≥3 is considered consistent with vasculitis. Sensitivity of post-therapeutic FDG PET/CT will be evaluated.

Moreover, standard uptake values (SUV) mean and maximum values in vascular regions will be calculated. A ratio SUV(wall)/SUV(blood pool) and a total metabolic burden (TMB) based on affected vascular volume and SUV mean values are obtained as measures of vascular wall inflammation.


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Study Type : Observational
Actual Enrollment : 24 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Fluorine-18-fluorodeoxyglucose Uptake in Large-Vessel Giant Cell Arteritis After Short-term, High-Dose Steroid Treatment - A Diagnostic Window of Opportunity?
Study Start Date : October 2014
Actual Primary Completion Date : September 2016
Actual Study Completion Date : September 2016

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
PET3
Post-therapeutic FDG PET/CT performed after 3 days of steroid treatment
Drug: PET3
Prednisolone 60 mg daily for 3 days

PET10
Post-therapeutic FDG PET/CT performed after 10 days of steroid treatment
Drug: PET10
Prednisolone 60 mg daily for 10 days




Primary Outcome Measures :
  1. Proportion of large vessel-GCA patients with post-therapeutic FDG uptake consistent with a diagnosis of large vessel giant cell arteritis [ Time Frame: Assessed after intervention (3 or 10 days of treatment, respectively) ]
    Proportion of patients with PET positive large vessel vasculitis defined as vascular FDG uptake≥3, semiquantitative assesment ad modum Meller


Secondary Outcome Measures :
  1. Change in quantitive uptake values (SUV) [ Time Frame: From baseline to post-treatments scan (3 or 10 days of treatment, respectively) ]
    The steroid induced change in FDG uptake assessed by; change in maximum standardized uptake values (SUV)

  2. Change in quantitive uptake values (TBR) [ Time Frame: From baseline to post-treatments scan (3 or 10 days of treatment, respectively) ]
    The steroid induced change in FDG uptake assessed by; change in target to background ratio (TBR)= SUVmax(artery)/SUVmean(venous blood pool)


Biospecimen Retention:   Samples With DNA
Temporal artery biopsies, whole blood, serum, plasma


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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Steroid-naive, newly-diagnosed giant cell arteritis patients
Criteria

Inclusion Criteria:

  1. Clinical suspicion of GCA; Cranial symptoms, new-onset extremity claudication or protracted constitutional symptoms (weight loss > 5 kilograms or fever >38C for > 3 weeks).
  2. C reactive protein >15 mg/l or erythrocyte sedimentation rate >40 mm/h
  3. FDG PET/CT verified LV-GCA (steroid-naive) defined by FDG uptake in the aortic wall and/or supra-aortic branches with FDG uptake score ≥3.

Exclusion Criteria:

  1. oral glucocorticoid treatment within the past month
  2. subcutaneously, intramuscularly, intraarticularly or intravenously administered glucocorticoid within the past 2 months
  3. treatment with DMARDs or other immunosuppressive therapy ongoing or within the past 3 months
  4. ongoing treatment with interleukin2
  5. any disease mimicking GCA, including

    • a) autoimmune diseases with possible aortitis; rheumatoid arthritis, Cogans syndrome, relapsing polychondritis, ankylosing spondylitis, systemic lupus erythematosus, Buerger's disease, Bechet's disease, inflammatory bowel disease
    • b) infections with possible aortitis: syphilis, known active current or history of recurrent tuberculosis, hepatitis or HIV
    • c) other large-vessel disease: sarcoidosis, neurofibromatosis, congenital coarctation, Marfans syndrome, Ehlers-Danlos syndrome, retroperitoneal fibrosis
  6. body weight of >150 kg.
  7. Previously diagnosed and treated for PMR or GCA

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03285945


Locations
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Denmark
Department of Rheumatology
Aarhus, Denmark, 8000
Sponsors and Collaborators
University of Aarhus
Investigators
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Study Chair: Ellen-Margrethe Hauge, Prof MD PhD Department of Rheumatology , Aarhus University Hospital

Publications:

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Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT03285945     History of Changes
Other Study ID Numbers: akutPET
First Posted: September 18, 2017    Key Record Dates
Last Update Posted: September 18, 2017
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by University of Aarhus:
Positron-Emission Tomography

Additional relevant MeSH terms:
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Connective Tissue Diseases
Arteritis
Giant Cell Arteritis
Polymyalgia Rheumatica
Vasculitis
Vascular Diseases
Cardiovascular Diseases
Vasculitis, Central Nervous System
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Skin Diseases, Vascular
Skin Diseases
Autoimmune Diseases
Immune System Diseases
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Fluorodeoxyglucose F18
Radiopharmaceuticals
Molecular Mechanisms of Pharmacological Action