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Not yet recruitingNCT06850324PARFUMEUpdated Feb 27, 2025

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 interventional study of 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 Atherosclerotic Disease, Carotid and Carotid Endarterectomy, sponsored by Ruud van Heeswijk. Not yet recruiting at 1 site in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-27.

Sponsored by Ruud van Heeswijk · Phase 2, Interventional, and Diagnostic

Phase
Phase 2
Study type
Interventional
Enrollment
18
Allocation
Not applicable
Ages
18 Years and older
Sex
All
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Study 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 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.

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Conditions studied

  • Atherosclerotic Disease, Carotid
  • Carotid Endarterectomy

Keywords

  • Mapping of Atherosclerotic Plaque Composition and Inflammation
  • Carotid Endarterectomy
  • ABL-101 Perfluorocarbon
  • Fluorine-19 Magnetic Resonance Imaging
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In context

Carotid Artery Diseases

248 studies on the registry are indexed under Carotid Artery Diseases; 56 are open to participants now.

This study's planned enrollment of 18 is below the median of 120 across 118 interventional studies indexed under Carotid Artery Diseases.

Browse Carotid Artery Diseases studies →

Lead sponsor

This is the only study on the registry with Ruud van Heeswijk as lead sponsor.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. 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,
  2. Age ≥ 18 years old,
  3. 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),
  4. Planned for an elective or semi-urgent carotid endarterectomy (CEA) in 2 days at the earliest based on the current institutional and international guidelines.

Exclusion criteria

Exclusion Criteria:

  1. Known thrombocytopenia (platelet count \<150x109/L) or history of platelet function disorder,
  2. MRI with gadolinium-based contrast agents within 24 hours of the MRI scan of this trial,
  3. Known allergy to ABL-101 or any of its constituents (including egg phospholipids),
  4. Known current infection,
  5. 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,
  6. Women who are pregnant or breast feeding,
  7. 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,
  8. Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc.,
  9. Participation in another study with investigational drug within the 30 days preceding and during the present study,
  10. Previous enrolment into the current study,
  11. Enrolment of the investigator, his/her family members, employees and other dependent persons,
  12. Inability to undergo MR imaging (e.g. incompatible implants, claustrophobia, etc.),
  13. 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.
  14. A priori refusal to receive information concerning fortuitous discoveries which may contribute to the prevention, diagnosis and treatment of the disease.
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Study design

Phase
Phase 2
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
18 participants (estimated)

Study arms

  • Experimental
    The perfluorocarbon tracer ABL-101 is infused as a single dosage of 3 mL/kg body weight

    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: 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).

Interventions

  • DrugABL-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.

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: The timepoint for primary outcome is the day of 19F MRI.

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Study locations

1 site
  • Centre Hospitalier Universitaire Vaudois
    Lausanne, Vaud 1011, Switzerland
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References and documents

Individual participant data

Plan to share: Yes

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 27, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06850324
Lead sponsor
Ruud van Heeswijk
Responsible party
Ruud van Heeswijk (Dr PD MER1, Centre Hospitalier Universitaire Vaudois) — Sponsor-investigator
First posted
Feb 27, 2025
Start date
Jul 1, 2025 (estimated)
Primary completion
Jun 30, 2027 (estimated)
Completion
Jun 30, 2028 (estimated)
Last update
Feb 27, 2025

Study contacts

Ruud van Heeswijk, Dr. SC., PD, MER1
Contact
ruud.van-heeswijk@chuv.ch
+41 (0)21 314 75 35

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.

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