6204237
Last Update Posted: 2025-01-30
Recruiting
All Genders accepted | 40 Years-85 Years |
10 Estimated Participants | No Expanded Access |
Interventional Study | Accepts healthy volunteers |
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)
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
Relevant conditions:
Peripheral Arterial Occlusive Disease
Critical Limb Ischemia
If you aren't sure if you meet the criteria above speak to your healthcare professional. Criteria may be updated but not reflected here, do not hesitate to contact the trial if you think are close to fitting criteria.
Inclusion criteria
Exclusion criteria
locations
Contact Information
Overall Contact
Verhaar, MD
anne-fleur@tracercro.com
0031622989025
Data sourced from ClinicalTrials.gov