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Clinical Trial Summary

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.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT06204237
Study type Interventional
Source Aplagon Oy
Contact Verhaar, MD
Phone 0031622989025
Email anne-fleur@tracercro.com
Status Recruiting
Phase Early Phase 1
Start date February 1, 2024
Completion date July 2024

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