Local delivery of CER-001 in advanced plaques Proof-of-concept for apoA-1 as initiator of reverse cholesterol transport (LOCATION)

Local delivery of CER-001 in advanced plaques Proof-of-concept for apoA-1 as initiator of reverse cholesterol transport (LOCATION) - LOCATION

Status

Active, not recruiting

Phases

Phase 2

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON40758

Enrollment

Registered

2014-06-23

Start date

2014-07-22

Completion date

Unknown

Last updated

2025-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

atherosclerosis vascular disease

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Patients must meet the following criteria for study entry: - Adult patients (either gender) * 50 years - Documented atherosclerotic vascular disease; defined as carotid artery stenosis > 50% on clinical MRI or ultrasound. - Clinically stable for at least 3 months prior to inclusion

Exclusion criteria

Exclusion criteria: Patients are not eligible if they meet one of the criteria listed below: - Creatinine clearance

Design outcomes

Primary

Measure	Time frame
89Zr-CER-001 uptake in the plaque over time, reported as Standardized Uptake Value (SUV), by means of PET imaging.	—

Secondary

Measure	Time frame
Further quantification of CER-001 uptake at the plaque - 89Zr-CER-001 uptake in the plaque over time assessed as the Target to Background Ratio (TBR), via PET imaging - Difference between SUV and TBR at the level of the plaque and SUV and TBR of non-diseased arterial wall on PET Relation between CER-001 uptake and plaque characteristics - Relation between SUV and TBR of the plaque on PET and structural plaque dimensions on MRI i.e. normalized wall index, vessel wall area. - Relation between SUV and TBR of the plaque and plaque permeability on DCE-MRI, i.e. Ktrans Relationship between the CER-001 uptake in the plaque by means of PET imaging reported as SUV of the plaque and the cholesterol efflux capacity.	—

Measure

Time frame

Further quantification of CER-001 uptake at the plaque - 89Zr-CER-001 uptake in the plaque over time assessed as the Target to Background Ratio (TBR), via PET imaging - Difference between SUV and TBR at the level of the plaque and SUV and TBR of non-diseased arterial wall on PET Relation between CER-001 uptake and plaque characteristics - Relation between SUV and TBR of the plaque on PET and structural plaque dimensions on MRI i.e. normalized wall index, vessel wall area. - Relation between SUV and TBR of the plaque and plaque permeability on DCE-MRI, i.e. Ktrans Relationship between the CER-001 uptake in the plaque by means of PET imaging reported as SUV of the plaque and the cholesterol efflux capacity.

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Countries

Netherlands

Outcome results