Giant Cell ArteritisPhase 2NCT03812302
Use of Gallium-68 HA-DOTATATE PET/CT in Giant Cell Arteritis (GCA)
A Phase 2 study testing 68-Ga HA-DOTATATE PET/CT in people with Giant Cell Arteritis, run by University of Alberta at 1 site in Canada.
Trial summary
The aim of this study is to compare the use of FDG PET/CT to Ga-68 HA-DOTATATE (abbreviated DOTATATE) PET/CT in patients with active giant cell arteritis (GCA) started on prednisone to understand if DOTATATE can identify more areas of active blood vessel inflammation than FDG. 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?
- 68-Ga HA-DOTATATE PET/CT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteCanada
- Study dates
- 9 Sep 2019to 30 Sep 2023
- Phase
- Phase 2
- 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
Who may be able to join
- Participants must:
- Meet the revised GCA diagnosis criteria (modified from ref 1)
- Have either newly-diagnosed or relapsing disease
- Have active disease (modified from ref 1, to remove ESR/CRP requirements)
- Have been empirically started on glucocorticoid treatment (or had baseline glucocorticoid dose increased, in the case of relapsers) ≤ 2 weeks of enrolment
- Participant must be have had (or will be willing to undergo) an urgent FDG-PET/CT as part of routine clinical care.
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- GCA diagnosis criteria (modified from ref 1, to remove ESR requirement).
- Age ≥ 50 years
- And at least 1 of a. or b. :
- Unequivocal cranial symptoms of GCA (new headache, scalp or temporal artery tenderness, ischemia-related vision loss, jaw/mouth claudication
- Unequivocal symptoms of polymyalgia rheumatica (PMR), defined as shoulder and/or hip girdle pain associated with inflammatory stiffness
- And at least 1 of a. or b.:
- Temporal artery biopsy revealing features of GCA
- Evidence of large-vessel vasculitis by angiography or cross-sectional imaging study such as magnetic resonance angiography (MRA), computed tomography angiography (CTA), or positron emission tomography-computed tomography (PET-CT)
Who cannot join
- Patients not meeting the above criteria or who are unable to provide informed consent will be excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluating the Use of Gallium-68 HA-DOTATATE Positron Emission Tomography/Computerized Tomography (PET/CT) in Patients With Giant Cell Arteritis (GCA.)
The aim of this study is to compare the use of FDG PET/CT to Ga-68 HA-DOTATATE (abbreviated DOTATATE) PET/CT in patients with active giant cell arteritis (GCA) started on prednisone to understand if DOTATATE can identify more areas of active blood vessel inflammation than FDG.
Read the detailed description
The aim of this study is to prospectively evaluate the potential use of 68-Ga HA-DOTATATE PET/CT for detecting medium-large vessel inflammation in a small number of GCA patients with active disease, as compared to FDG PET/CT, and to understand if DOTATATE uptake correlates with disease activity. Fifteen patients with active GCA (either newly-diagnosed or recently relapsed disease) who are receiving glucocorticoids will be enrolled. Participants will undergo baseline FDG PET/CT and baseline DOTATATE PET/CT scan. Tracer uptake will be described in 8 major vascular territories. DOTATATE PET/CT will be repeated again in 6 months, and tracer uptake will be correlated to clinical disease activity, and medication use.
- Conditions
- Giant Cell Arteritis
- Being tested
- 68-Ga HA-DOTATATE PET/CT
- 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.
68-Ga HA-DOTATATE PET/CTDiagnostic test
See arm description.
| Study group | Role | What they receive |
|---|---|---|
| DOTATATE | Experimental | All 15 GCA patients will undergo 68-Ga HA-DOTATATE PET/CT imaging at baseline, in addition to FDG PET/CTA (as part of standard of care). DOTATATE PET/CT imaging will be repeated at 6 months follow-up. Receives: Diagnostic Test: 68-Ga HA-DOTATATE PET/CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of FDG vs DOTATATE vascular uptake in individual vascular territories using target-blood pool ratios (TBR)
Measured: time 0 (baseline)
Secondary outcomes (4)
Qualitative comparison of FDG vs DOTATATE vascular uptake in individual vascular (scores 0-3) territories using visual uptake scores
Measured: time 0 (baseline)
Changes in vascular DOTATATE uptake scores over time (quantitatively and qualitatively)
Measured: 6 months
Correlation between vascular DOTATATE uptake scores and clinical status
Measured: 0 and 6 months
Correlation between vascular DOTATATE uptake scores and cumulative glucocorticoid exposure
Measured: 0 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2019
- Study start9 Sep 2019
- Primary completion30 Sep 2023
- Study completion30 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Giant Cell ArteritisStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 68-Ga HA-DOTATATE PET/CT will be performed in all participants as part of study protocol. Participants will receive an intravenous infusion of 3MBq/kg of 68Ga HA-DOTATATE (to max 200 MBq), followed by CT and PET imaging 60 minutes later. Tracer uptake in each vascular territory will be interpreted qualitatively and quantitatively.
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alison Clifford, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03812302
- Sponsor's protocol ID
- Pro00085448
- Status last verified
- Oct 2023
- First submitted
- 18 Jan 2019
- Last updated
- 18 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Unizony SH, Dasgupta B, Fisheleva E, Rowell L, Schett G, Spiera R, Zwerina J, Harari O, Stone JH. Design of the tocilizumab in giant cell arteritis trial. Int J Rheumatol. 2013;2013:912562. doi: 10.1155/2013/912562. Epub 2013 Apr 7.
PubMed 23653652Clifford AH, Abele J, Hung R, Wuest F, Andersson J, Pike S, Yacyshyn E, Lenza E, Jickling G, Raggi P, Cohen Tervaert JW. Comparison of [18F]fluorodeoxyglucose and [68Ga]Gallium DOTA-TATE in patients with active giant cell arteritis. EJNMMI Rep. 2025 Mar 1;9(1):7. doi: 10.1186/s41824-025-00242-y.
PubMed 40021570
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Use of Gallium-68 HA-DOTATATE Positron Emission Tomography/Computerized Tomography (PET/CT) in Patients With Giant Cell Arteritis (GCA.)
- ClinicalTrials.gov ID
- NCT03812302
- Acronym / sponsor ID
- Pro00085448
- Conditions
- Giant Cell Arteritis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Study start
- 9 Sep 2019 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 30 Sep 2023 (actual)
- First posted
- 23 Jan 2019 (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.
The aim of this study is to compare the use of FDG PET/CT to Ga-68 HA-DOTATATE (abbreviated DOTATATE) PET/CT in patients with active giant cell arteritis (GCA) started on prednisone to understand if DOTATATE can identify more areas of active blood vessel inflammation than FDG.
Detailed description
The aim of this study is to prospectively evaluate the potential use of 68-Ga HA-DOTATATE PET/CT for detecting medium-large vessel inflammation in a small number of GCA patients with active disease, as compared to FDG PET/CT, and to understand if DOTATATE uptake correlates with disease activity. Fifteen patients with active GCA (either newly-diagnosed or recently relapsed disease) who are receiving glucocorticoids will be enrolled. Participants will undergo baseline FDG PET/CT and baseline DOTATATE PET/CT scan. Tracer uptake will be described in 8 major vascular territories. DOTATATE PET/CT will be repeated again in 6 months, and tracer uptake will be correlated to clinical disease activity, and medication use.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 68-Ga HA-DOTATATE PET/CT will be performed in all participants as part of study protocol. Participants will receive an intravenous infusion of 3MBq/kg of 68Ga HA-DOTATATE (to max 200 MBq), followed by CT and PET imaging 60 minutes later. Tracer uptake in each vascular territory will be interpreted qualitatively and quantitatively.
| Arm | Type | Receives |
|---|---|---|
| DOTATATE | Experimental | Diagnostic Test: 68-Ga HA-DOTATATE PET/CTAll 15 GCA patients will undergo 68-Ga HA-DOTATATE PET/CT imaging at baseline, in addition to FDG PET/CTA (as part of standard of care). DOTATATE PET/CT imaging will be repeated at 6 months follow-up. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Meet the revised GCA diagnosis criteria (modified from ref 1)
- Have either newly-diagnosed or relapsing disease
- Have active disease (modified from ref 1, to remove ESR/CRP requirements)
- Have been empirically started on glucocorticoid treatment (or had baseline glucocorticoid dose increased, in the case of relapsers) ≤ 2 weeks of enrolment
- Participant must be have had (or will be willing to undergo) an urgent FDG-PET/CT as part of routine clinical care.
Key exclusion criteria (1 listed)
- Patients not meeting the above criteria or who are unable to provide informed consent will be excluded.
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 |
|---|---|---|
| 68-Ga HA-DOTATATE PET/CTSee arm description. | Diagnostic test | DOTATATE |
Primary outcome
Comparison of FDG vs DOTATATE vascular uptake in individual vascular territories using target-blood pool ratios (TBR)
Time frame: time 0 (baseline)
4 secondary outcomes
Qualitative comparison of FDG vs DOTATATE vascular uptake in individual vascular (scores 0-3) territories using visual uptake scores
Time frame: time 0 (baseline)
Changes in vascular DOTATATE uptake scores over time (quantitatively and qualitatively)
Time frame: 6 months
Correlation between vascular DOTATATE uptake scores and clinical status
Time frame: 0 and 6 months
Correlation between vascular DOTATATE uptake scores and cumulative glucocorticoid exposure
Time frame: 0 and 6 months
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 Oct 2023.
- Results publication: PubMed 23653652Unizony SH, Dasgupta B, Fisheleva E, Rowell L, Schett G, Spiera R, Zwerina J, Harari O, Stone JH. Design of the tocilizumab in giant cell arteritis trial. Int J Rheumatol. 2013;2013:912562. doi: 10.1155/2013/912562. Epub 2013 Apr 7.
- Derived from this study: PubMed 40021570Clifford AH, Abele J, Hung R, Wuest F, Andersson J, Pike S, Yacyshyn E, Lenza E, Jickling G, Raggi P, Cohen Tervaert JW. Comparison of [18F]fluorodeoxyglucose and [68Ga]Gallium DOTA-TATE in patients with active giant cell arteritis. EJNMMI Rep. 2025 Mar 1;9(1):7. doi: 10.1186/s41824-025-00242-y.
- Individual participant dataSharing planned: No
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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.
Alison Clifford principal investigator
University of Alberta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 68-Ga HA-DOTATATE PET/CT in people with Giant Cell Arteritis, run by University of Alberta at 1 site in Canada.
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 14 inclusion and 1 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 Oct 2023. 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 Canada. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Comparison of FDG vs DOTATATE vascular uptake in individual vascular territories using target-blood pool ratios (TBR) (time frame: time 0 (baseline)). 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 NCT03812302, which also lists 2 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 Oct 2023.