Giant Cell ArteritisNCT03409913
Diagnostic Accuracy of FDG PET/CT of Cranial Arteries in GCA
An observational study of Giant Cell Arteritis, run by University of Aarhus at 1 site in Denmark.
Trial summary
A case-control study to evaluate the diagnostic accuracy of FDG uptake in cranial arteries by FDG PET/CT in the diagnosis of giant cell arteritis. 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?
- FDG PET/CT
- Type of treatment
- Surgery or procedure
- How many people
- 106 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Oct 2014to 31 Dec 2017
- 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: All patients are sampled from tertiary hospital. Cases are identified in an established cohort of patients suspected og GCA in whom clinical assessment, including imaging procedures were performed before treatment. Controls are sampled among malignant melanoma patients who had a clinically indicated follow-up FDG PET/CT to evaluate disease freedom/progression.
Who may be able to join
- Cases:
- 1) age ≥50 years, 2) CRP>15mg/l or ESR>40mm/h, 3) either a) cranial symptoms, b) new-onset extremity claudication or c) weight loss >5 kilograms or fever>38oC for >3 weeks and a clinical diagnosis of giant cell arteritis judged by expert rheumatologist.
- Controls:
- age-(+/-3 years) and sex-matched malignant melanoma (MM) patients
- follow-up metastatic-disease-free FDG PET/CT ≥6 months after MM resection
Who cannot join
- Previous diagnosis of polymyalgia or giant cell arteritis
- immunosuppresive treatment within last month
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Conventional FDG PET/CT Accurately Diagnoses Temporal Arteritis in Glucocorticoid-naïve GCA Patients: a Case-control Study
A case-control study to evaluate the diagnostic accuracy of FDG uptake in cranial arteries by FDG PET/CT in the diagnosis of giant cell arteritis.
Read the detailed description
Although older studies argue that FDG PET/CT cannot demonstrate inflammation in cranial arteries, e.g. temporal and maxillary arteries, the resolution of modern PET systems may have improved, making a case for FDG PET/CT. FDG PET/CT is increasingly used in giant cell arteritis (GCA) diagnosis due to its excellent diagnostic accuracy considering large-vessel involvement. In case of uncommon distribution of vessel involvement or marginally increased large-vessel FDG uptake, FDG PET/CT-specificity may be compromised. Hence, recognising FDG uptake in cranial arteries potentially adds to FDG PET/CTs diagnostic accuracy.
Objectives To evaluate the diagnostic accuracy of conventional FDG PET/CT of the cranial arteries in the diagnosis of GCA.
Methods In a cohort of consecutively included glucocorticoid-naïve patients suspected of new-onset GCA, patients with a clinical GCA diagnosis will be identified. Conventional FDG PET/CT and vascular ultrasound(US) was performed before treatment. Patients were referred for a temporal artery biopsy (TAB).
Controls are age-(+/- 3 years) and sex-matched malignant melanoma (MM) patients who had a follow-up metastatic-disease-free FDG PET/CT ≥6 months after MM resection.
Images will be assessed by 5 nuclear medicine physicians blinded to clinical symptoms and findings. Temporal (TA), maxillary (MA) and vertebral (VA) arteries will be visually assessed. Arterial FDG uptake more than FDG uptake in surrounding tissue is considered positive. Sensitivity, specificity and interreader agreement will be evaluated.
- Conditions
- Giant Cell Arteritis
- Being tested
- FDG PET/CT
- Keywords
- positron emissions tomography, diagnostic accuracy, case-control
- 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.
FDG PET/CTRadiation
Also called Temporal artery biopsy, Vascular ultrasound, Inflammatory biomarkers
Conventional FDG PET/CT including head in order to asses cranial arteries.
| Study group | Role | What they receive |
|---|---|---|
| GCA cases | In a cohort of patients suspected of GCA based on the following inclusion criteria were 1) age ≥50 years, 2) CRP>15mg/l or ESR>40mm/h, 3) either a) cranial symptoms, b) new-onset extremity claudication or c) weight loss >5 kilograms or fever>38oC for >3 weeks, patients with a clinical diagnosis of GCA is identified. Receives: Radiation: FDG PET/CT | |
| controls | Age-(+/- 3 years) and sex-matched malignant melanoma (MM) patients who had a follow-up metastatic-disease-free FDG PET/CT ≥6 months after MM resection Receives: Radiation: FDG PET/CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
PET positivity
Presence of FDG uptake in temporal, maxillary and/or vertebral arteries assessed in order to evaluate sensitivity and specificity of PET of cranial arteries in the diagnosis of GCA
Measured: Time of diagnosis/pre-treatment (cases)
Secondary outcomes (3)
Full-fillment of ACR criteria
PET sensitivity and specificity in the subpopulation of GCA patients full filling ACR criteria
Measured: Time of diagnosis
Temporal artery biopsy
Correlation between temporal artery biopsy result and temporal artery FDG uptake
Measured: Time of diagnosis
Temporal artery ultrasound
Correlation between temporal artery ultrasound result and temporal artery FDG uptake
Measured: Time of diagnosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2018
- Study start1 Oct 2014
- Primary completion31 Dec 2017
- Study completion31 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Giant Cell ArteritisStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lars Christian Gormsen, MD, PhD, Study chair, Department of Nuclear Medicine and PET centre, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03409913
- Sponsor's protocol ID
- Cranial_GCA_PET
- Status last verified
- Jan 2018
- First submitted
- 18 Jan 2018
- Last updated
- 24 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Conventional FDG PET/CT Accurately Diagnoses Temporal Arteritis in Glucocorticoid-naïve GCA Patients: a Case-control Study
- ClinicalTrials.gov ID
- NCT03409913
- Acronym / sponsor ID
- Cranial_GCA_PET
- Conditions
- Giant Cell Arteritis
- Keywords
- positron emissions tomography, diagnostic accuracy, case-control
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- 1 Oct 2014 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 24 Jan 2018 (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.
A case-control study to evaluate the diagnostic accuracy of FDG uptake in cranial arteries by FDG PET/CT in the diagnosis of giant cell arteritis.
Detailed description
Although older studies argue that FDG PET/CT cannot demonstrate inflammation in cranial arteries, e.g. temporal and maxillary arteries, the resolution of modern PET systems may have improved, making a case for FDG PET/CT. FDG PET/CT is increasingly used in giant cell arteritis (GCA) diagnosis due to its excellent diagnostic accuracy considering large-vessel involvement. In case of uncommon distribution of vessel involvement or marginally increased large-vessel FDG uptake, FDG PET/CT-specificity may be compromised. Hence, recognising FDG uptake in cranial arteries potentially adds to FDG PET/CTs diagnostic accuracy.
Objectives To evaluate the diagnostic accuracy of conventional FDG PET/CT of the cranial arteries in the diagnosis of GCA.
Methods In a cohort of consecutively included glucocorticoid-naïve patients suspected of new-onset GCA, patients with a clinical GCA diagnosis will be identified. Conventional FDG PET/CT and vascular ultrasound(US) was performed before treatment. Patients were referred for a temporal artery biopsy (TAB).
Controls are age-(+/- 3 years) and sex-matched malignant melanoma (MM) patients who had a follow-up metastatic-disease-free FDG PET/CT ≥6 months after MM resection.
Images will be assessed by 5 nuclear medicine physicians blinded to clinical symptoms and findings. Temporal (TA), maxillary (MA) and vertebral (VA) arteries will be visually assessed. Arterial FDG uptake more than FDG uptake in surrounding tissue is considered positive. Sensitivity, specificity and interreader agreement will be evaluated.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GCA cases | – | Radiation: FDG PET/CTIn a cohort of patients suspected of GCA based on the following inclusion criteria were 1) age ≥50 years, 2) CRP>15mg/l or ESR>40mm/h, 3) either a) cranial symptoms, b) new-onset extremity claudication or c) weight loss >5 kilograms or fever>38oC for >3 weeks, patients with a clinical diagnosis of GCA is identified. |
| controls | – | Radiation: FDG PET/CTAge-(+/- 3 years) and sex-matched malignant melanoma (MM) patients who had a follow-up metastatic-disease-free FDG PET/CT ≥6 months after MM resection |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients are sampled from tertiary hospital. Cases are identified in an established cohort of patients suspected og GCA in whom clinical assessment, including imaging procedures were performed before treatment. Controls are sampled among malignant melanoma patients who had a clinically indicated follow-up FDG PET/CT to evaluate disease freedom/progression.
Key inclusion criteria (5 listed)
- 1) age ≥50 years, 2) CRP>15mg/l or ESR>40mm/h, 3) either a) cranial symptoms, b) new-onset extremity claudication or c) weight loss >5 kilograms or fever>38oC for >3 weeks and a clinical diagnosis of giant cell arteritis judged by expert rheumatologist.
- age-(+/-3 years) and sex-matched malignant melanoma (MM) patients
- follow-up metastatic-disease-free FDG PET/CT ≥6 months after MM resection
Key exclusion criteria (2 listed)
- Previous diagnosis of polymyalgia or giant cell arteritis
- immunosuppresive treatment within last month
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 |
|---|---|---|
| FDG PET/CTAlso: Temporal artery biopsy, Vascular ultrasound, Inflammatory biomarkersConventional FDG PET/CT including head in order to asses cranial arteries. | Radiation | GCA cases, controls |
Primary outcome
PET positivity
Time frame: Time of diagnosis/pre-treatment (cases)
Presence of FDG uptake in temporal, maxillary and/or vertebral arteries assessed in order to evaluate sensitivity and specificity of PET of cranial arteries in the diagnosis of GCA
3 secondary outcomes
Full-fillment of ACR criteria
Time frame: Time of diagnosis
Temporal artery biopsy
Time frame: Time of diagnosis
Temporal artery ultrasound
Time frame: Time of diagnosis
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 24 Jan 2018.
- Individual participant dataSharing planned: Undecided
Related trials for Giant Cell Arteritis
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The Applanation Tonometry in GCA Pilot
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Optic Nerve Sheath Ultrasound in Giant Cell Arteritis
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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.
Lars Christian Gormsen, MD, PhD study chair
Department of Nuclear Medicine and PET centre, 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 5 inclusion and 2 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 24 Jan 2018. 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?
PET positivity (time frame: Time of diagnosis/pre-treatment (cases)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Jan 2018; AzTrials last refreshed its copy on 8 Nov 2026.