Atherosclerotic Disease, CarotidPhase 2PARFUMENCT06850324
Evaluate the Precision of ABL-101 Perfluorocarbon and Fluorine-19 MRI for the Mapping of Atherosclerotic Plaque Composition and Inflammation in Patients Undergoing Carotid Endarterectomy
A Phase 2 study testing ABL-101 is administered at 3mL/kg body weight (to a notional maximum of 100kg, rounded to the nearest ml), at the rate of 15 mL/min (900ml/hour). in people with Atherosclerotic Disease, Carotid and Carotid Endarterectomy, run by Ruud van Heeswijk at 1 site in Switzerland.
Trial summary
This study is aimed at patients suffering from carotid atherosclerosis. In the presence of atherosclerosis of the carotid arteries, one of the treatments that can be proposed is carotid endarterectomy, the aim of which is to remove the atherosclerotic plaque that obstructs the carotid artery and therefore increases… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atherosclerotic Disease, Carotid, Carotid Endarterectomy
- What is being tested?
- ABL-101 is administered at 3mL/kg body weight (to a notional maximum of 100kg, rounded to the nearest ml), at the rate of 15 mL/min (900ml/hour).
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Jul 2025to 30 Jun 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written Informed Consent signed by the patient if capable of discernment or by the legally authorized representative if the patient is considered non capable of discernment or authorisation received from independent physician,
- Age ≥ 18 years old,
- Symptomatic atherosclerotic stenosis of the internal carotid artery ≥ 50% or asymptomatic atherosclerotic stenosis of the internal carotid artery ≥ 60% confirmed on at least two non-invasive imaging studies (Doppler, CT angiography, or MR angiography),
- Planned for an elective or semi-urgent carotid endarterectomy (CEA) in 2 days at the earliest based on the current institutional and international guidelines.
Who cannot join
- Known thrombocytopenia (platelet count <150x109/L) or history of platelet function disorder,
- MRI with gadolinium-based contrast agents within 24 hours of the MRI scan of this trial,
- Known allergy to ABL-101 or any of its constituents (including egg phospholipids),
- Known current infection,
- Any current medical condition causing impaired immunity (e.g. HIV infection, hyposplenism) or use of systemic immunosuppressant medication except for inhaled, nasal intra-articular or topical corticosteroids) on an ongoing basis or within the preceding 30 days,
- Women who are pregnant or breast feeding,
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- Other clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction, advanced cardiac failure, etc.), Known or suspected non-compliance, drug or alcohol abuse,
- Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc.,
- Participation in another study with investigational drug within the 30 days preceding and during the present study,
- Previous enrolment into the current study,
- Enrolment of the investigator, his/her family members, employees and other dependent persons,
- Inability to undergo MR imaging (e.g. incompatible implants, claustrophobia, etc.),
- Any incapacitated patient that is not expected to recover to a point where they will personally be capable of discernment and able to provide informed consent.
- A priori refusal to receive information concerning fortuitous discoveries which may contribute to the prevention, diagnosis and treatment of the disease.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site
Centre Hospitalier Universitaire Vaudois
Lausanne, Canton of Vaud, 1011
Ruud van Heeswijk, Dr. PD MER, +41 (0)21 314 75 35, ruud.van-heeswijk@chuv.ch
About this study
Official title: A Proof of Concept Study to Evaluate the Precision of ABL-101 Perfluorocarbon and Fluorine-19 Magnetic Resonance Imaging in Mapping of Atherosclerotic Plaque Composition and Inflammation in Patients Undergoing Carotid Endarterectomy
This study is aimed at patients suffering from carotid atherosclerosis. In the presence of atherosclerosis of the carotid arteries, one of the treatments that can be proposed is carotid endarterectomy, the aim of which is to remove the atherosclerotic plaque that obstructs the carotid artery and therefore increases the risk of developing a stroke. The risk of rupture of these plaques is primarily assessed by anatomical medical imaging: the degree of stenosis (narrowing) that the plaque causes most often informs the decision whether or not to proceed with surgery. However, it is well established that the degree of stenosis is not a very precise decision criterion: some plaques would never have ruptured, while others have ruptured even though no surgical intervention had been performed. It has since been discovered that the degree of inflammation is a much more accurate predictor of future rupture, but there is currently no reliable non-invasive imaging marker to measure plaque inflammation.
In this study, the investigators therefore evaluate a new marker, the perfluorocarbon ABL-101, for non-invasive imaging of inflammation in atherosclerotic plaque. To assess the marker's effectiveness in quantifying inflammation in plaque, the plaque will be analyzed microscopically after removal to obtain a more accurate measure of the degree of inflammation. This will enable us to assess the effectiveness of the non-invasive marker injection method versus the more invasive microscopic analysis of the removed plaque.
ABL-101 consists of a perfluorocarbon (PFC) emulsion, a liquid mixture in which PFC particles are dispersed. PFCs are chemical compounds containing only carbon and fluorine, and are known for their ability to transport large quantities of oxygen. Totally inert, PFCs cannot be broken down by the body and are eliminated naturally. Due to their small size, these particles are also captured by certain immune system cells and, combined with 19F-MRI, constitute a marker of inflammation.
- Being tested
- ABL-101 is administered at 3mL/kg body weight (to a notional maximum of 100kg, rounded to the nearest ml), at the rate of 15 mL/min (900ml/hour).
- Keywords
- Mapping of Atherosclerotic Plaque Composition and Inflammation, Carotid Endarterectomy, ABL-101 Perfluorocarbon, Fluorine-19 Magnetic Resonance Imaging
- Medical subject headings
- Carotid Artery Diseases, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABL-101 is administered at 3mL/kg body weight (to a notional maximum of 100kg, rounded to the nearest ml), at the rate of 15 mL/min (900ml/hour).Drug
The doses of ABL-101 is administered using an IV infusion pump in the arm at 3mL/kg body weight (to a notional maximum of 100kg, rounded to the nearest ml), at the rate of 15 mL/min (900ml/hour). Patients will undergo a 1 hour-imaging with 19F MRI, 16h-36h after end of PFC infusion.
| Study group | Role | What they receive |
|---|---|---|
| The perfluorocarbon tracer ABL-101 is infused as a single dosage of 3 mL/kg body weight | Experimental | The doses of ABL-101 is administered using an IV infusion pump in the arm at 3mL/kg body weight (to a notional maximum of 100kg, rounded to the nearest ml), at the rate of 15 mL/min (900ml/hour).
Patients will undergo a 1 hour-imaging with 19F MRI, 16h-36h after end of PFC infusion. Receives: Drug: ABL-101 is administered at 3mL/kg body weight (to a notional maximum of 100kg, rounded to the nearest ml), at the rate of 15 mL/min (900ml/hour). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between 19F MRI signal measured in the carotid plaque to be excised and CD45+ leukocytes number per mm2 in the excised plaque
The primary outcome of this study is the correlation between:
- The average of 19F MRI signal measured in the carotid plaque to be excised, and
- The average of CD45+ leukocytes number per mm2 in the excised plaque
Measured: The timepoint for primary outcome is the day of 19F MRI.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2025
- Study start1 Jul 2025 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atherosclerotic Disease, CarotidStudies 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
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Open label proof-of-concept phase II study
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruud van Heeswijk
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ruud van Heeswijk, Centre Hospitalier Universitaire Vaudois
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06850324
- Sponsor's protocol ID
- 23-113
- Acronym
- PARFUME
- Status last verified
- Feb 2025
- First submitted
- 24 Feb 2025
- Last updated
- 27 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Proof of Concept Study to Evaluate the Precision of ABL-101 Perfluorocarbon and Fluorine-19 Magnetic Resonance Imaging in Mapping of Atherosclerotic Plaque Composition and Inflammation in Patients Undergoing Carotid Endarterectomy
- ClinicalTrials.gov ID
- NCT06850324
- Acronym / sponsor ID
- PARFUME / 23-113
- Keywords
- Mapping of Atherosclerotic Plaque Composition and Inflammation, Carotid Endarterectomy, ABL-101 Perfluorocarbon, Fluorine-19 Magnetic Resonance Imaging
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Ruud van HeeswijkUniversity, hospital or other
- Study start
- 1 Jul 2025 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 27 Feb 2025 (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.
This study is aimed at patients suffering from carotid atherosclerosis. In the presence of atherosclerosis of the carotid arteries, one of the treatments that can be proposed is carotid endarterectomy, the aim of which is to remove the atherosclerotic plaque that obstructs the carotid artery and therefore increases the risk of developing a stroke. The risk of rupture of these plaques is primarily assessed by anatomical medical imaging: the degree of stenosis (narrowing) that the plaque causes most often informs the decision whether or not to proceed with surgery. However, it is well established that the degree of stenosis is not a very precise decision criterion: some plaques would never have ruptured, while others have ruptured even though no surgical intervention had been performed. It has since been discovered that the degree of inflammation is a much more accurate predictor of future rupture, but there is currently no reliable non-invasive imaging marker to measure plaque inflammation.
In this study, the investigators therefore evaluate a new marker, the perfluorocarbon ABL-101, for non-invasive imaging of inflammation in atherosclerotic plaque. To assess the marker's effectiveness in quantifying inflammation in plaque, the plaque will be analyzed microscopically after removal to obtain a more accurate measure of the degree of inflammation. This will enable us to assess the effectiveness of the non-invasive marker injection method versus the more invasive microscopic analysis of the removed plaque.
ABL-101 consists of a perfluorocarbon (PFC) emulsion, a liquid mixture in which PFC particles are dispersed. PFCs are chemical compounds containing only carbon and fluorine, and are known for their ability to transport large quantities of oxygen. Totally inert, PFCs cannot be broken down by the body and are eliminated naturally. Due to their small size, these particles are also captured by certain immune system cells and, combined with 19F-MRI, constitute a marker of inflammation.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open label proof-of-concept phase II study
| Arm | Type | Receives |
|---|---|---|
| The perfluorocarbon tracer ABL-101 is infused as a single dosage of 3 mL/kg body weight | Experimental | Drug: ABL-101 is administered at 3mL/kg body weight (to a notional maximum of 100kg, rounded to the nearest ml), at the rate of 15 mL/min (900ml/hour).The doses of ABL-101 is administered using an IV infusion pump in the arm at 3mL/kg body weight (to a notional maximum of 100kg, rounded to the nearest ml), at the rate of 15 mL/min (900ml/hour). Patients will undergo a 1 hour-imaging with 19F MRI, 16h-36h after end of PFC infusion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Written Informed Consent signed by the patient if capable of discernment or by the legally authorized representative if the patient is considered non capable of discernment or authorisation received from independent physician,
- Age ≥ 18 years old,
- Symptomatic atherosclerotic stenosis of the internal carotid artery ≥ 50% or asymptomatic atherosclerotic stenosis of the internal carotid artery ≥ 60% confirmed on at least two non-invasive imaging studies (Doppler, CT angiography, or MR angiography),
- Planned for an elective or semi-urgent carotid endarterectomy (CEA) in 2 days at the earliest based on the current institutional and international guidelines.
Key exclusion criteria (14 listed)
- Known thrombocytopenia (platelet count <150x109/L) or history of platelet function disorder,
- MRI with gadolinium-based contrast agents within 24 hours of the MRI scan of this trial,
- Known allergy to ABL-101 or any of its constituents (including egg phospholipids),
- Known current infection,
- Any current medical condition causing impaired immunity (e.g. HIV infection, hyposplenism) or use of systemic immunosuppressant medication except for inhaled, nasal intra-articular or topical corticosteroids) on an ongoing basis or within the preceding 30 days,
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 |
|---|---|---|
| ABL-101 is administered at 3mL/kg body weight (to a notional maximum of 100kg, rounded to the nearest ml), at the rate of 15 mL/min (900ml/hour).The doses of ABL-101 is administered using an IV infusion pump in the arm at 3mL/kg body weight (to a notional maximum of 100kg, rounded to the nearest ml), at the rate of 15 mL/min (900ml/hour). Patients will undergo a 1 hour-imaging with 19F MRI, 16h-36h after end of PFC infusion. | Drug | The perfluorocarbon tracer ABL-101 is infused as a single dosage of 3 mL/kg body weight |
Primary outcome
Correlation between 19F MRI signal measured in the carotid plaque to be excised and CD45+ leukocytes number per mm2 in the excised plaque
Time frame: The timepoint for primary outcome is the day of 19F MRI.
The primary outcome of this study is the correlation between: * The average of 19F MRI signal measured in the carotid plaque to be excised, and * The average of CD45+ leukocytes number per mm2 in the excised plaque
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2025.
- Individual participant dataSharing planned: Yes
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ABL-101 is administered at 3mL/kg body weight (to a notional maximum of 100kg, rounded to the nearest ml), at the rate of 15 mL/min (900ml/hour). in people with Atherosclerotic Disease, Carotid and Carotid Endarterectomy, run by Ruud van Heeswijk at 1 site in Switzerland.
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 4 inclusion and 14 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: opening soon, as of the sponsor's last update on 27 Feb 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 Switzerland. 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?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ruud van Heeswijk, Dr. SC., PD, MER1 (+41 (0)21 314 75 35, ruud.van-heeswijk@chuv.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between 19F MRI signal measured in the carotid plaque to be excised and CD45+ leukocytes number per mm2 in the excised plaque (time frame: The timepoint for primary outcome is the day of 19F MRI.). 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 27 Feb 2025.