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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

NCT06850324 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2025-02-27

No results posted yet for this 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.

Conditions

  • Atherosclerotic Disease, Carotid
  • Carotid Endarterectomy

Interventions

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.

Sponsors & Collaborators

  • Ruud van Heeswijk

    lead OTHER

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-01
Primary Completion
2027-06-30
Completion
2028-06-30

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06850324 on ClinicalTrials.gov