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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) | Clinical Trials | Clareo Health

RECRUITINGEARLY_PHASE1

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)

Safety, Tolerability, and Biodistribution of [89Zr]Zr-DFO-APAC (Phase 0) in Subjects With Peripheral Arterial Occlusive Disease / Critical Limb Ischemia (PAOD/CLI) and Healthy Volunteers - an Open Label PET Study (Acronyms: 89Zr = Zirconium-89, DFO = Desferrioxamine, APAC = AntiPlatelet AntiCoagulant, PET/CT = Positron Emission Tomography/Computed Tomography)

NCT06204237•Aplagon Oy

View on ClinicalTrials.gov

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

Age

40 - 85 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•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 during the first 15 days to prevent transmission of 89-Zr to a partner of childbearing potential.
•9. Patients should be able to understand all study-related information in Dutch.
•1. Male or female volunteers 40-80 years old, inclusive.
+6 more criteria

Exclusion Criteria

•1. Acute limb-threatening ischemia (e.g., embolic disease).
•2. An existing aneurysm that requires surgical intervention.
•3. Medical history of, or condition known to be associated with impaired hemostasis, such as an increased intracranial bleeding risk e.g., previous history of intracranial hemorrhage, subarachnoidal bleeding, hemorrhagic stroke, or gastrointestinal or retroperitoneal bleeding, or any inherited or acquired bleeding disorder, such as von Willebrand disease or hemophilia.
•4. Any cerebrovascular event (including transient ischemic attack, thrombotic or embolic stroke) within the past year.
•5. Diagnosis of autoimmune (Type 1, or latent autoimmune diabetes in adults (LADA))diabetes mellitus.
•6. HbA1c \>10% at screening.
•7. Current use of anticoagulant therapy (warfarin, apixaban, rivaroxaban, dabigatran, edoxaban, fondaparinux, or any heparin derivative) for any medical reason.
•8. Patients treated with combined antiplatelet agents, excluding a single agent, such as acetylsalicylic acid (up to 100 mg QD) or clopidogrel (up to 75 mg QD).
•9. Use of non-steroidal anti-inflammatory medications within 2 weeks prior to dosing with \[89Zr\]Zr-DFO-APAC. If pain relief is required, paracetamol may be used.
•10. Use of selective serotonin reuptake inhibitor (SSRI) medications within 2 weeks prior to dosing with \[89Zr\]Zr-DFO-APAC.
+36 more criteria

Locations (1)

The University Medical Center Groningen

Groningen, Netherlands

Key Dates

Start Date

February 1, 2024

Primary Completion Date

June 1, 2025

Completion Date

June 1, 2025

Last Updated

January 30, 2025

Enrollment

ESTIMATED participants

Conditions

Peripheral Arterial Occlusive DiseaseCritical Limb Ischemia

Interventions

[89Zr]Zr-DFO-APAC

DRUG

PET/CT scan

RADIATION

Contacts

Verhaar, MD

CONTACT

0031622989025 anne-fleur@tracercro.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 30, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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)

Inclusion Criteria

Exclusion Criteria

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