Peripheral Arterial Occlusive DiseaseEarly Phase 1CHASENCT06204237
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)
A Early Phase 1 study testing [89Zr]Zr-DFO-APAC and PET/CT scan in people with Peripheral Arterial Occlusive Disease and Critical Limb Ischemia, run by Aplagon Oy at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 40 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Peripheral Arterial Occlusive Disease, Critical Limb Ischemia
- What is being tested?
- [89Zr]Zr-DFO-APAC and PET/CT scan
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Feb 2024to Jun 2025
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Males and females aged 40-85 years.
- PAOD/CLI patients Rutherford categories 1-4 and category 5 with Wlfl wound grade of 0 or 1.
- Estimated glomerular filtration rate (eGFR) >46 mL/min/1.73 m2 as per calculation of Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI).
- 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.
- 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.
- Provision of valid informed consent and capability to communicate well with the investigator.
Show all 16Show fewer
- Pre-menopausal woman must be willing to practise highly effective contraception for 195 days after IMP administration.
- 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.
- Patients should be able to understand all study-related information in Dutch.
- Male or female volunteers 40-80 years old, inclusive.
- Healthy status defined by the absence of evidence of any active or chronic disease following a detailed medical and surgical history, a complete physical examination including vital signs, 12-lead ECG, hematology, blood chemistry, serology and urinalysis.
- No diagnosis of diabetes, pre-diabetes or insulin resistance.
- Normal eGFR as per calculation of Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI).
- Premenopausal woman must be willing to practise highly effective contraception for 195 days after IMP administration.
- 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
- Healthy volunteers should be able to understand all study-related information in Dutch.
Who cannot join
- Acute limb-threatening ischemia (e.g., embolic disease).
- An existing aneurysm that requires surgical intervention.
- 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.
- Any cerebrovascular event (including transient ischemic attack, thrombotic or embolic stroke) within the past year.
- Diagnosis of autoimmune (Type 1, or latent autoimmune diabetes in adults (LADA))diabetes mellitus.
- HbA1c >10% at screening.
Show all 46Show fewer
- Current use of anticoagulant therapy (warfarin, apixaban, rivaroxaban, dabigatran, edoxaban, fondaparinux, or any heparin derivative) for any medical reason.
- 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).
- 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.
- Use of selective serotonin reuptake inhibitor (SSRI) medications within 2 weeks prior to dosing with [89Zr]Zr-DFO-APAC.
- Major surgery, major trauma or any endovascular intervention within the past 90 days or organ biopsy or diagnostic angiography within the past 30 days prior to the screening visit.
- Uncontrolled arterial hypertension (persistent systolic blood pressure \> 160 mmHg or diastolic blood pressure \> 100 mmHg).
- Hemoglobin <8.0 mmol/L (130 g/l) (men) or <7.5 mmol/L (120 g/l) (women) at screening, or platelet count <150 x 109/L and leukocyte count >12 x 109/L.
- Clinically significantly prolonged plasma prothrombin time (PT) and activated plasma partial thromboplastin time (APTT) (> 1.2-fold).
- Patients with a medical history of heparin-induced thrombocytopenia.
- Patients with known significant liver disease, incl. an alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) level > 2.5 x ULN (Upper limit normal) at screening.
- A diagnosis of severe chronic kidney disease, defined as having a glomerular filtration rate (GFR) category 4 or 5 (GFR ≤ 45 mL/min/1.73 m2) and albuminuria stage A3 albumin:creatinine ratio (ACR) of >300 mg/g).
- Patients with an active malignancy or who have received treatment for any malignancy within 1 year before the screening visit, except for localized basal cell or squamous cell skin cancer that has been cured at least 90 days before screening.
- Patients with a history of metastatic malignancy.
- Women who are pregnant or lactating.
- Patients with a known allergy or hypersensitivity to heparin or heparin products, and/or antiplatelet agents (e.g., aspirin or clopidogrel).
- Participation in an investigational drug or device study within 30 days prior to screening.
- Patients who have ever received treatment with an antibody or gene therapy product or participated in a clinical trial with such agents (unless there is evidence that they received placebo only).
- Patients with known antiphospholipid antibody syndrome or other thrombophilia.
- Patients with a medical history of severe infection or vasculitis due to an autoimmune disease, inflammatory bowel disease (IBD) or Crohn's disease.
- Any concomitant disease or condition that could interfere with, or the treatment of which might interfere with, the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to the subject.
- Patients unable or unwilling to comply with the protocol or to cooperate fully with the investigator or site personnel.
- Patients with anamnestic history of drug abuse (defined as illicit drug use) or anamnestic history of alcohol abuse (defined as regular or daily consumption of more than 4 alcoholic drinks per day) within the past 12 months.
- Any sign or symptom of PAOD/CLI or other cardiovascular disease.
- Abnormal ankle-brachial index (ABI) at rest and/or decrease of ABI following treadmill exercise.
- Use of any anticoagulant or antiplatelet (not including aspirin at recommended doses) agent within the recent 12 months before screening.
- Any regular prescription or over-the-counter medication, except for vitamins.
- Medical history of heparin-induced thrombocytopenia.
- Medical history of atrial fibrillation and/or those with a mechanical heart valve.
- Major surgery, major trauma or organ biopsy within the past 90 days before screening.
- Medical history of, or any condition, associated with an increased bleeding risk.
- Arterial hypertension (systolic blood pressure >140 mmHg or diastolic blood pressure >90 mmHg.
- Subjects with a medical history of, or an existing aneurysm.
- Hemoglobin <8.0 mmol/L (130 g/l) (men) or <7.5 mmol/L (120 g/l) (women) at screening or platelet count \&lt; 150 x 109/L or leukocyte count above normal (12 x 109/L).
- Clinically significantly prolonged prothrombin time (PT) and activated partial thromboplastin time (APTT) (> 1.2-fold).
- Participation in an investigational drug or device study within 30 days prior to screening.
- Subjects who have ever received treatment with an antibody or gene therapy product or participated in a clinical trial with such agents (unless there is evidence that they were received placebo only).
- Subjects with known thrombophilia.
- Women who are pregnant or lactating.
- Subjects unable or unwilling to comply with the protocol or to cooperate fully with the investigator or site personnel.
- Subjects with anamnestic history of drug abuse (defined as illicit drug use) or a anamnestic history of alcohol abuse (defined as regular or daily consumption of more than 4 alcoholic drinks per day) within the past 3 months.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
The University Medical Center Groningen
Groningen
Anne-Fleur Verhaar, MD
About this study
Official title: 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)
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.
- Being tested
- [89Zr]Zr-DFO-APAC, PET/CT scan
- Medical subject headings
- Peripheral Arterial Occlusive Disease 1, Chronic Limb-Threatening Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[89Zr]Zr-DFO-APACDrug
All participants will receive a single i.v. injection of [89Zr]Zr-DFO-APAC 15 MBq (Megabecquerel).
PET/CT scanRadiation
The IMP administration will be followed by whole-body PET/CT scanning (day 1), and repeated PET/CT scans on days 3 and 7.
| Study group | Role | What they receive |
|---|---|---|
| [89Zr]Zr-DFO-APAC | Experimental | Not described Receives: Drug: [89Zr]Zr-DFO-APAC; Radiation: PET/CT scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of treatment emergent adverse events (AE) (safety and tolerability)
Occurrence and severity of one or more treatment-emergent AEs from the time of i.v. administration of [89Zr]Zr-DFO-APAC until the end of the follow-up period, and changes in plasma/serum clinical chemistry, hematology, coagulation variables, vital signs, ECG, and physical examination findings.
Measured: Study duration (Up to 21 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2024
- Study start1 Feb 2024
- Primary completionJun 2025 (estimated)
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Arterial Occlusive DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aplagon Oy
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- TRACER Europe BV
- Responsible party
- Sponsor
- Investigators
- Schelto Kruijff, MD, Prof, Principal investigator, University Medical Center Groningen, NL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06204237
- Sponsor's protocol ID
- 2023-505287-11-01
- Other IDs
- 17489, 2023
- Acronym
- CHASE
- Status last verified
- Sep 2024
- First submitted
- 3 Jan 2024
- Last updated
- 30 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT06204237
- Acronym / sponsor ID
- CHASE / 2023-505287-11-01
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Aplagon OyIndustry (pharma, biotech, devices)
- Collaborators
- TRACER Europe BV
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 12 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| [89Zr]Zr-DFO-APAC | Experimental | Drug: [89Zr]Zr-DFO-APAC, Radiation: PET/CT scan |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Males and females aged 40-85 years.
- PAOD/CLI patients Rutherford categories 1-4 and category 5 with Wlfl wound grade of 0 or 1.
- Estimated glomerular filtration rate (eGFR) >46 mL/min/1.73 m2 as per calculation of Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI).
- 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.
- 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.
Key exclusion criteria (46 listed)
- Acute limb-threatening ischemia (e.g., embolic disease).
- An existing aneurysm that requires surgical intervention.
- 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.
- Any cerebrovascular event (including transient ischemic attack, thrombotic or embolic stroke) within the past year.
- Diagnosis of autoimmune (Type 1, or latent autoimmune diabetes in adults (LADA))diabetes mellitus.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| [89Zr]Zr-DFO-APACAll participants will receive a single i.v. injection of [89Zr]Zr-DFO-APAC 15 MBq (Megabecquerel). | Drug | [89Zr]Zr-DFO-APAC |
| PET/CT scanThe IMP administration will be followed by whole-body PET/CT scanning (day 1), and repeated PET/CT scans on days 3 and 7. | Radiation | [89Zr]Zr-DFO-APAC |
Primary outcome
Incidence of treatment emergent adverse events (AE) (safety and tolerability)
Time frame: Study duration (Up to 21 days)
Occurrence and severity of one or more treatment-emergent AEs from the time of i.v. administration of [89Zr]Zr-DFO-APAC until the end of the follow-up period, and changes in plasma/serum clinical chemistry, hematology, coagulation variables, vital signs, ECG, and physical examination findings.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2025.
- Individual participant dataSharing planned: No
Related trials for Peripheral Arterial Occlusive Disease
Active, not recruiting
SUCCESS (SelUtion, Safety, effiCaCy, hEalth economicS and promS) PTA Study
Peripheral Artery Disease
RecruitingPhase 3
Reducing Adverse Vascular Outcomes With Factor XI Inhibition in Adult Participants With Peripheral Artery Disease
Peripheral Artery Disease (PAD)
Recruiting
The THOR IDE Study
Peripheral Artery Disease, Peripheral Artery Stenosis
Not yet recruiting
Daily Stretching to Improve Walking in Older Patients With Peripheral Artery Disease: The STRETCH PAD Study
Peripheral Artery Disease (PAD), Intermittent Claudication
Enrolling by invitationEarly Phase 1
Truway Diagnostic Tools in Primary Care
Chronic Disease, Type 2 Diabetes Mellitus (T2DM), Obesity, Overweight
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Schelto Kruijff, MD, Prof principal investigator
University Medical Center Groningen, NL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing [89Zr]Zr-DFO-APAC and PET/CT scan in people with Peripheral Arterial Occlusive Disease and Critical Limb Ischemia, run by Aplagon Oy at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 46 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Verhaar, MD (0031622989025, anne-fleur@tracercro.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of treatment emergent adverse events (AE) (safety and tolerability) (time frame: Study duration (Up to 21 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2025.