NCT06204237 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)
| NCT ID | NCT06204237 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | Aplagon Oy |
| Condition | Peripheral Arterial Occlusive Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 10 participants |
| Start Date | 2024-02-01 |
| Primary Completion | 2025-06 |
Trial Parameters
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Brief 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.
Eligibility Criteria
INCLUSION CRITERIA PATIENTS 1. Males and females aged 40-85 years. 2. PAOD/CLI patients Rutherford categories 1-4 and category 5 with Wlfl wound grade of 0 or 1. 3. Estimated glomerular filtration rate (eGFR) \>46 mL/min/1.73 m2 as per calculation of Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI). 4. CT angiography with contrast agent performed of within 3 months of the patients' first PET-scan as part of diagnostics of PAOD, with results available in the subject's medical records. 5. No surgical or endovascular intervention for PAOD within 1 year of the first PET/CT-scan or planned between inclusion and the patients' last PET-scan. 6. Provision of valid informed consent and capability to communicate well with the investigator. 7. Pre-menopausal woman must be willing to practise highly effective contraception for 195 days after IMP administration. 8. Men must be willing to practise highly effective contraception for 105 days after IMP administration, including condom use d