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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 68-Ga HA-DOTATATE PET/CT | Diagnostic Test | See arm description. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of FDG vs DOTATATE vascular uptake in individual vascular territories using target-blood pool ratios (TBR) | time 0 (baseline) |
| Measure | Description | Time Frame |
|---|---|---|
| Qualitative comparison of FDG vs DOTATATE vascular uptake in individual vascular (scores 0-3) territories using visual uptake scores | time 0 (baseline) | |
| Changes in vascular DOTATATE uptake scores over time (quantitatively and qualitatively) | 6 months |
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Inclusion Criteria:
Participants must:
GCA diagnosis criteria (modified from ref 1, to remove ESR requirement).
Age ≥ 50 years
And at least 1 of a. or b. :
And at least 1 of a. or b.:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alison Clifford | University of Alberta | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alberta | Edmonton | Alberta | T6G 2G3 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23653652 | Result | 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. | |
| 40021570 | Derived | Clifford 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. |
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| ID | Term |
|---|---|
| D013700 | Giant Cell Arteritis |
| ID | Term |
|---|---|
| D020293 | Vasculitis, Central Nervous System |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D002561 | Cerebrovascular Disorders |
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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.
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| Correlation between vascular DOTATATE uptake scores and clinical status | 0 and 6 months |
| Correlation between vascular DOTATATE uptake scores and cumulative glucocorticoid exposure | 0 and 6 months |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001167 | Arteritis |
| D014657 | Vasculitis |
| D017445 | Skin Diseases, Vascular |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |