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

September 15, 2017 updated by: University of Aarhus

Fluorine-18-fluorodeoxyglucose Uptake in Large-Vessel Giant Cell Arteritis After Short-term, High-Dose Steroid Treatment - A Diagnostic Window of Opportunity?

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

24

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aarhus, Denmark, 8000
        • Department of rheumatology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

48 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Steroid-naive, newly-diagnosed giant cell arteritis patients

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Assessed after intervention (3 or 10 days of treatment, respectively)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
From baseline to post-treatments scan (3 or 10 days of treatment, respectively)
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)
From baseline to post-treatments scan (3 or 10 days of treatment, respectively)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aarhus

Investigators

  • Study Chair: Ellen-Margrethe Hauge, Prof MD PhD, Department of Rheumatology , Aarhus University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Actual)

September 1, 2016

Study Completion (Actual)

September 1, 2016

Study Registration Dates

First Submitted

October 12, 2016

First Submitted That Met QC Criteria

September 15, 2017

First Posted (Actual)

September 18, 2017

Study Record Updates

Last Update Posted (Actual)

September 18, 2017

Last Update Submitted That Met QC Criteria

September 15, 2017

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • akutPET

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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