Giant Cell ArteritisSPARTANCT05854927
Impact of the Spatial Resolution of Several Contrast-enhanced 3D T1-WI Sequences When Diagnosing Giant Cell Arteritis (GCA)
An observational study of Giant Cell Arteritis, run by Fondation Ophtalmologique Adolphe de Rothschild at 1 site in France.
Trial summary
Giant cell arteritis (GCA) (or Horton's disease) is a segmental and focal inflammatory arteritis affecting large and medium-sized arteries. Its incidence is estimated at 17.8/100,000 in subjects over 50 years old (and 46/100,000 in subjects over 70 years old). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Giant Cell Arteritis
- What is being tested?
- 3D T1 MRI sequences injected with fat saturation and black blood
- How many people
- 133 participants
- Where
- 1 siteFrance
- Study dates
- 10 Jan 2024to Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participation in the study will be offered to all patients referred to imaging for an injected MRI for suspected GCA.
Who may be able to join
- Patient over 18 years of age
- Referred for imaging for an injected MRI for suspected GCA
- Suspicion of GCA based on the presence of three major criteria or two major and one minor criteria defined as follows:
- Major criteria: Age > 50 years; Headache of recent onset; Claudication of the jaw, tongue or swallowing disorders; Visual problems (blindness, diplopia, blurred vision - including visual accidents occurring during the first week of treatment); Sedimentation rate at 1st hour > 50 and/or CRP > 8mg/l
- Minor criteria: Hypersensitivity or induration of the scalp or presence of nodules remote from the temporal artery; Temporal artery abnormalities on palpation; Facial pain or feeling of facial edema; General signs (fever >38°C, weight loss >10%, anorexia, malaise, asthenia).
- Cconsent to participate in the study
- Affiliated or beneficiary of a social security plan
Who cannot join
- Newly diagnosed malignant disease (diagnosed less than one year prior to inclusion)
- Active infectious disease
- Autoimmune disease (especially but not limited to: Wegener's disease, Takayasu vasculitis, ANCA vasculitis, rheumatoid arthritis, lupus erythematosus, periarteritis nodosa).
- Systemic corticosteroid therapy for more than 10 days at high dose (>0.5mg/kg/d of prednisone)
- Contraindication to MRI
- Patient benefiting from a legal protection measure
- Pregnant or breastfeeding woman
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Hôpital Fondation Adolphe de Rothschild
Paris
Amélie YAVCHITZ, +33148036454, ayavchitz@for.paris
About this study
Giant cell arteritis (GCA) (or Horton's disease) is a segmental and focal inflammatory arteritis affecting large and medium-sized arteries. Its incidence is estimated at 17.8/100,000 in subjects over 50 years old (and 46/100,000 in subjects over 70 years old). This disease remains a severe pathology due in particular to its vascular, ophthalmological, neurological, cardiac and aortic complications. In case of suspected CAG, management is a real therapeutic emergency. Indeed, only corticosteroid therapy started as early as possible can prevent the occurrence of these complications.
The gold standard for the diagnosis of CAG has long been the temporal artery biopsy, but imaging is now considered as a 1st line diagnostic examination for the diagnosis of CAG according to the EULAR 2018 recommendations. Notably, temporal artery MRI has excellent sensitivity and specificity for diagnosis.
Read more
However, the high diagnostic performance of MRI has been achieved by performing 3D T1 black blood and fat saturation sequences in high resolution (<0.7mm), which are not accessible in all centers in France and worldwide.
The realization of identical sequences with a lower resolution could allow a greater generalization of these sequences and improve the diagnostic management of GCA patients, including in non-expert centers.
The objective of our study is to investigate the diagnostic performance of several 3D T1 black blood and fat saturation sequences for the diagnosis of GCA.
- Conditions
- Giant Cell Arteritis
- Being tested
- 3D T1 MRI sequences injected with fat saturation and black blood
- 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.
3D T1 MRI sequences injected with fat saturation and black bloodDiagnostic test
3D T1 MRI sequences injected with fat saturation and black blood
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity of unilateral or bilateral inflammation of the temporal arteries and/or ophthalmic arteries or other branch of the internal carotid arteries with a 3D PDw MRI sequence for GCA diagnosis
The gold standard for the diagnosis of GCA will be based on a multidisciplinary evaluation (internists, neurologists, ophthalmologists) of the clinical and biological data in the patient's file at 3 months of inclusion, according to the criteria of the ACR (American College of Rheumatology) 2021, blinded to the MRI scans performed at inclusion.
MRI imaging will be reviewed by two radiologists (one junior and one senior) to assess inflammation in each artery of interest. Consensus will be sought in the event of disagreement between the two readers.
Measured: Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2023
- Study start10 Jan 2024
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
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 Fondation Ophtalmologique Adolphe de RothschildThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 133 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondation Ophtalmologique Adolphe de Rothschild
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05854927
- Sponsor's protocol ID
- ALR_2022_14
- Acronym
- SPARTA
- Status last verified
- Dec 2025
- First submitted
- 27 Apr 2023
- Last updated
- 5 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of the Spatial Resolution of Several Contrast-enhanced 3D T1-WI Sequences When Diagnosing Giant Cell Arteritis (GCA)
- ClinicalTrials.gov ID
- NCT05854927
- Acronym / sponsor ID
- SPARTA / ALR_2022_14
- Conditions
- Giant Cell Arteritis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 133 participants (estimated)
- Lead sponsor
- Fondation Ophtalmologique Adolphe de RothschildResearch network
- Study start
- 10 Jan 2024 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 11 May 2023 (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) (or Horton's disease) is a segmental and focal inflammatory arteritis affecting large and medium-sized arteries. Its incidence is estimated at 17.8/100,000 in subjects over 50 years old (and 46/100,000 in subjects over 70 years old). This disease remains a severe pathology due in particular to its vascular, ophthalmological, neurological, cardiac and aortic complications. In case of suspected CAG, management is a real therapeutic emergency. Indeed, only corticosteroid therapy started as early as possible can prevent the occurrence of these complications.
The gold standard for the diagnosis of CAG has long been the temporal artery biopsy, but imaging is now considered as a 1st line diagnostic examination for the diagnosis of CAG according to the EULAR 2018 recommendations. Notably, temporal artery MRI has excellent sensitivity and specificity for diagnosis.
However, the high diagnostic performance of MRI has been achieved by performing 3D T1 black blood and fat saturation sequences in high resolution (<0.7mm), which are not accessible in all centers in France and worldwide.
The realization of identical sequences with a lower resolution could allow a greater generalization of these sequences and improve the diagnostic management of GCA patients, including in non-expert centers.
The objective of our study is to investigate the diagnostic performance of several 3D T1 black blood and fat saturation sequences for the diagnosis of GCA.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participation in the study will be offered to all patients referred to imaging for an injected MRI for suspected GCA.
Key inclusion criteria (7 listed)
- Patient over 18 years of age
- Referred for imaging for an injected MRI for suspected GCA
- Suspicion of GCA based on the presence of three major criteria or two major and one minor criteria defined as follows:
- Cconsent to participate in the study
- Affiliated or beneficiary of a social security plan
Key exclusion criteria (7 listed)
- Newly diagnosed malignant disease (diagnosed less than one year prior to inclusion)
- Active infectious disease
- Autoimmune disease (especially but not limited to: Wegener's disease, Takayasu vasculitis, ANCA vasculitis, rheumatoid arthritis, lupus erythematosus, periarteritis nodosa).
- Systemic corticosteroid therapy for more than 10 days at high dose (>0.5mg/kg/d of prednisone)
- Contraindication to MRI
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 |
|---|---|---|
| 3D T1 MRI sequences injected with fat saturation and black blood3D T1 MRI sequences injected with fat saturation and black blood | Diagnostic test | – |
Primary outcome
Sensitivity of unilateral or bilateral inflammation of the temporal arteries and/or ophthalmic arteries or other branch of the internal carotid arteries with a 3D PDw MRI sequence for GCA diagnosis
Time frame: Month 3
The gold standard for the diagnosis of GCA will be based on a multidisciplinary evaluation (internists, neurologists, ophthalmologists) of the clinical and biological data in the patient's file at 3 months of inclusion, according to the criteria of the ACR (American College of Rheumatology) 2021, blinded to the MRI scans performed at inclusion. MRI imaging will be reviewed by two radiologists (one junior and one senior) to assess inflammation in each artery of interest. Consensus will be sought in the event of disagreement between the two readers.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2026.
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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.
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 Fondation Ophtalmologique Adolphe de Rothschild at 1 site in France.
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 7 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 5 Jan 2026. 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 France. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity of unilateral or bilateral inflammation of the temporal arteries and/or ophthalmic arteries or other branch of the internal carotid arteries with a 3D PDw MRI sequence for GCA diagnosis (time frame: Month 3). 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 5 Jan 2026.