Safety, Tolerability, and Biodistribution of [89Zr]Zr-DFO-APAC in Subjects With PAOD/CLI and Healthy Volunteers (Acronyms: 89Zr = Zirconium-89, DFO = Desferrioxamine, APAC = AntiPlatelet AntiCoagulant, PET/CT = Positron Emission Tomography/Computed Tomography)
Recruiting now · Early Phase 1
Conditions studied: Peripheral Arterial Occlusive Disease, Critical Limb Ischemia
In brief
The goal of this Phase 0 clinical trial is to evaluate safety and biodistribution of \[89Zr\]Zr-DFO-APAC in patients with peripheral arterial occlusive disease / critical limb ischemia (PAOD/CLI) and healthy volunteers. The main questions it aims to answer are: * What is the safety, tolerability and pharmacokinetic profile (PK: both systemic and local vascular injury site-specific PK) of \[89Zr\]Zr-DFO-APAC? * What is the biodistribution and internal radiation dosimetry of the tracer dose of \[89Zr\]Zr-DFO-APAC? * What is the binding and retention time of \[89Zr\]Zr-DFO-APAC to arteries and atherosclerotic or microvascular lesions? Participants will receive a dose of the \[89Zr\]Zr-DFO-APAC (IMP) and PET/CT imaging is performed on days 1, 3 and 7, and follow-up visit 7-14 days post IMP dosing.
Key facts
- Study ID
- NCT06204237
- Run by
- Aplagon Oy
- People needed
- 10
- Starts
- 2024-02-01
- Expected to finish
- 2025-06-01
- Last updated by the study team
- 2025-01-30
Who can join
Age: 40 and older, up to 85. Sex: any. Healthy volunteers: accepted.
Where it is running
- The University Medical Center Groningen — Groningen, Netherlands (enrolling)
Full record on ClinicalTrials.gov
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