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

NCT03285945 | Completed

• 1 other identifier: akutPET
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Giant Cell Arteritis

Keywords

Positron-Emission Tomography

Outcome Measures

Primary Outcomes (1)

• Proportion of large vessel-GCA patients with post-therapeutic FDG uptake consistent with a diagnosis of large vessel giant cell arteritis

  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 Outcomes (2)

• Change in quantitive uptake values (SUV)

  From baseline to post-treatments scan (3 or 10 days of treatment, respectively)

• Change in quantitive uptake values (TBR)

  From baseline to post-treatments scan (3 or 10 days of treatment, respectively)

Study Arms (2)

PET3

Post-therapeutic FDG PET/CT performed after 3 days of steroid treatment

Drug: PET3

PET10

Post-therapeutic FDG PET/CT performed after 10 days of steroid treatment

Drug: PET10

Interventions

PET3 DRUG

Prednisolone 60 mg daily for 3 days

PET3

PET10 DRUG

Prednisolone 60 mg daily for 10 days

PET10

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Steroid-naive, newly-diagnosed giant cell arteritis patients

You may qualify if:

• Clinical suspicion of GCA; Cranial symptoms, new-onset extremity claudication or protracted constitutional symptoms (weight loss \> 5 kilograms or fever \>38C for \> 3 weeks).
• C reactive protein \>15 mg/l or erythrocyte sedimentation rate \>40 mm/h
• 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.

You may not qualify if:

• oral glucocorticoid treatment within the past month
• subcutaneously, intramuscularly, intraarticularly or intravenously administered glucocorticoid within the past 2 months
• treatment with DMARDs or other immunosuppressive therapy ongoing or within the past 3 months
• ongoing treatment with interleukin2
• 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
• body weight of \>150 kg.
• Previously diagnosed and treated for PMR or GCA

Sponsors & Collaborators

• University of Aarhus: lead

Study Sites (1)

Department of Rheumatology

Aarhus, 8000, Denmark

Location

Related Publications (4)

• Puppo C, Massollo M, Paparo F, Camellino D, Piccardo A, Shoushtari Zadeh Naseri M, Villavecchia G, Rollandi GA, Cimmino MA. Giant cell arteritis: a systematic review of the qualitative and semiquantitative methods to assess vasculitis with 18F-fluorodeoxyglucose positron emission tomography. Biomed Res Int. 2014;2014:574248. doi: 10.1155/2014/574248. Epub 2014 Sep 1.

  PMID: 25254211 BACKGROUND

• Stellingwerff MD, Brouwer E, Lensen KDF, Rutgers A, Arends S, van der Geest KSM, Glaudemans AWJM, Slart RHJA. Different Scoring Methods of FDG PET/CT in Giant Cell Arteritis: Need for Standardization. Medicine (Baltimore). 2015 Sep;94(37):e1542. doi: 10.1097/MD.0000000000001542.

  PMID: 26376404 BACKGROUND

• Fuchs M, Briel M, Daikeler T, Walker UA, Rasch H, Berg S, Ng QK, Raatz H, Jayne D, Kotter I, Blockmans D, Cid MC, Prieto-Gonzalez S, Lamprecht P, Salvarani C, Karageorgaki Z, Watts R, Luqmani R, Muller-Brand J, Tyndall A, Walter MA. The impact of 18F-FDG PET on the management of patients with suspected large vessel vasculitis. Eur J Nucl Med Mol Imaging. 2012 Feb;39(2):344-53. doi: 10.1007/s00259-011-1967-x. Epub 2011 Nov 10.

  PMID: 22072285 BACKGROUND

• Prieto-Gonzalez S, Depetris M, Garcia-Martinez A, Espigol-Frigole G, Tavera-Bahillo I, Corbera-Bellata M, Planas-Rigol E, Alba MA, Hernandez-Rodriguez J, Grau JM, Lomena F, Cid MC. Positron emission tomography assessment of large vessel inflammation in patients with newly diagnosed, biopsy-proven giant cell arteritis: a prospective, case-control study. Ann Rheum Dis. 2014 Jul;73(7):1388-92. doi: 10.1136/annrheumdis-2013-204572. Epub 2014 Mar 24.

  PMID: 24665112 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Temporal artery biopsies, whole blood, serum, plasma

MeSH Terms

Conditions

Giant Cell Arteritis

Condition Hierarchy (Ancestors)

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

Study Officials

• Ellen-Margrethe Hauge, Prof MD PhD

  Department of Rheumatology , Aarhus University Hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2016
• First Posted: September 18, 2017
• Study Start: October 1, 2014
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: September 18, 2017

Record last verified: 2016-10

Locations

DK (1)