Giant Cell ArteritisNCT03285945
FDG Uptake in Large-Vessel Giant Cell Arteritis After Short-term, High-Dose Steroid Treatment
An observational study of Giant Cell Arteritis, run by University of Aarhus at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Giant Cell Arteritis
- What is being tested?
- PET3 and PET10
- How many people
- 24 participants
- Where
- 1 siteDenmark
- Study dates
- Oct 2014to Sep 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Steroid-naive, newly-diagnosed giant cell arteritis patients
Who may be able to join
- 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.
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Giant Cell Arteritis
- Being tested
- PET3, PET10
- Keywords
- Positron-Emission Tomography
- Medical subject headings
- Giant Cell Arteritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET3Drug
Prednisolone 60 mg daily for 3 days
PET10Drug
Prednisolone 60 mg daily for 10 days
| Study group | Role | What they receive |
|---|---|---|
| PET3 | Post-therapeutic FDG PET/CT performed after 3 days of steroid treatment Receives: Drug: PET3 | |
| PET10 | Post-therapeutic FDG PET/CT performed after 10 days of steroid treatment Receives: Drug: PET10 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Assessed after intervention (3 or 10 days of treatment, respectively)
Secondary outcomes (2)
Change in quantitive uptake values (SUV)
The steroid induced change in FDG uptake assessed by; change in maximum standardized uptake values (SUV)
Measured: From baseline to post-treatments scan (3 or 10 days of treatment, respectively)
Change in quantitive uptake values (TBR)
The steroid induced change in FDG uptake assessed by; change in target to background ratio (TBR)= SUVmax(artery)/SUVmean(venous blood pool)
Measured: From baseline to post-treatments scan (3 or 10 days of treatment, respectively)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2017
- Study startOct 2014
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Giant Cell ArteritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ellen-Margrethe Hauge, Prof MD PhD, Study chair, Department of Rheumatology , Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03285945
- Sponsor's protocol ID
- akutPET
- Status last verified
- Oct 2016
- First submitted
- 12 Oct 2016
- Last updated
- 18 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 25254211Stellingwerff 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.
PubMed 26376404Fuchs 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.
PubMed 22072285Prieto-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.
PubMed 24665112
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fluorine-18-fluorodeoxyglucose Uptake in Large-Vessel Giant Cell Arteritis After Short-term, High-Dose Steroid Treatment - A Diagnostic Window of Opportunity?
- ClinicalTrials.gov ID
- NCT03285945
- Acronym / sponsor ID
- akutPET
- Conditions
- Giant Cell Arteritis
- Keywords
- Positron-Emission Tomography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 18 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PET3 | – | Drug: PET3Post-therapeutic FDG PET/CT performed after 3 days of steroid treatment |
| PET10 | – | Drug: PET10Post-therapeutic FDG PET/CT performed after 10 days of steroid treatment |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Steroid-naive, newly-diagnosed giant cell arteritis patients
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PET3Prednisolone 60 mg daily for 3 days | Drug | PET3 |
| PET10Prednisolone 60 mg daily for 10 days | Drug | PET10 |
Primary outcome
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
2 secondary outcomes
Change in quantitive uptake values (SUV)
Time frame: 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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2017.
- Background: PubMed 25254211Puppo 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.
- Background: PubMed 26376404Stellingwerff 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.
- Background: PubMed 22072285Fuchs 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.
- Background: PubMed 24665112Prieto-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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ellen-Margrethe Hauge, Prof MD PhD study chair
Department of Rheumatology , Aarhus University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Giant Cell Arteritis, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03285945, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2017.