Ignite Creation Date:
2024-05-06 @ 8:18 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06335888
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-05
First Post:
2024-03-21
Brief Title:
A Clinical Trial to Investigate 18F-AzaFol in the Diagnosis of Large Vessel Vasculitis
Sponsor:
Insel Gruppe AG University Hospital Bern
Organization:
Insel Gruppe AG University Hospital Bern
Study Overview
Official Title:
Cross-over Randomized Open-label Single-centre Phase II Clinical Trial to Investigate 18F-AzaFol in the Diagnosis of Large Vessel Vasculitis
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CRAFT
Brief Summary:
The goal of this open-label clinical trial is to evaluate the efficacy of AzaFol-PETCT in the diagnosis of GCA giant cell arteritis to compare AzaFol- with 2-18FFDG-PETCT and to assess the safety and tolerability of AzaFol in subjects with suspicion of GCA
Participants will undergo AzaFol-PETCT imaging at a single timepoint
Participants will undergo AzaFol-PETCT imaging at a single timepoint
Detailed Description:
Giant cell arteritis GCA is the most common systemic vasculitis in the elderly population 2-18FFluor-2-desoxy-D-glucose 2-18FFDG positron emission tomography PET computed tomography CT is performed to diagnose GCA standard of care SOC but unable to reliably distinguish atherosclerosis from vasculitis Activated macrophages express folate receptor FR-β and are enriched in inflamed vascular tissue in GCA 3-Aza-2-18FFluoro-Folic Acid AzaFol is a nuclear tracer targeting FRβ The investigators hypothesize that AzaFol is a specific and reliable tracer to visualize activated macrophages in GCA and therefore might improve the discrimination of vasculitic and atherosclerotic lesions as compared to 2-18FFDG-PETCT
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None