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18F-GP1 PET-CT to Detect Bioprosthetic Aortic Valve Thrombosis

18F-GP1 Positron Emission Tomography-computed Tomography to Detect Bioprosthetic Aortic Valve Thrombosis; the Biothrombus Study.

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04073875
Enrollment
53
Registered
2019-08-29
Start date
2019-10-22
Completion date
2021-10-13
Last updated
2024-09-19

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

Conditions

Aortic Valve Disease, Thrombosis Cardiac

Brief summary

18F-GP1 binds with high affinity to the glycoprotein IIb/IIIa receptors on activated platelets. 18F-GP1 PET-CT has recently demonstrated favourable safety, pharmacokinetic, biodistribution and diagnostic performance for the in vivo identification of venous and arterial thrombemboli.

Detailed description

Aortic stenosis is the most common reason for valvular interventions in the developed world, with rates projected to increase as the population ages. Aortic valve replacement remains the only recognised treatment available. Bioprostheses are far more common than mechanical prostheses, particularly with increasing rates of transcatheter heart valve use. Bioprothetic valves are less durable than mechanical valves and are subject to deterioration which may lead to clinical heart failure and the need for re-intervention. Long-term results with surgical bioprostheses are well reported, with valve deterioration rates of less than 15% at 10 years. These data, however, rely on re-operation rather than echocardiographic measures, suggesting that the true incidence of structural valve deterioration is underestimated. Valve thrombosis is increasingly recognised as a potential contributor to leaflet degeneration and has been detected in participants undergoing both surgical aortic valve replacement and transcatheter aortic valve implantation. The role of valve thrombosis as an early trigger for calcification and subsequent valve degeneration has not been addressed. The true incidence of valve thrombosis and its impact on clinical outcomes is unknown due to the lack of a sufficiently sensitive non-invasive imaging modality to detect early subclinical thrombosis. Current observational data suggests rates of 12 to 40%, based on computed tomography findings. There is a clinical need for a more sensitive non-invasive method of detecting valve thrombosis.

Interventions

DIAGNOSTIC_TEST18F-GP1

18F-GP1 PET-CT scan

Sponsors

Life Molecular Imaging SA
CollaboratorINDUSTRY
British Heart Foundation
CollaboratorOTHER
University of Edinburgh
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* ability to give informed consent * \>1 month post-surgical or transcatheter aortic valve replacement

Exclusion criteria

* Inability to give informed consent * Pregnancy or breastfeeding * Contraindications to iodinated contrast * Contraindications to anticoagulation * Use of anticoagulants during the post-operative period prior to screening * Extreme claustrophobia * Chronic kidney disease (with estimated glomerular filtration rate \<30 mL/min/1.73m2) * Metastatic malignancy * Inability to tolerate the supine position

Design outcomes

Primary

MeasureTime frameDescription
Prevalence of 18F-GP1 PET-CT bioprosthetic aortic valve uptake2 yearsPrevalence of 18F-GP1 PET-CT bioprosthetic aortic valve uptake as measured by standardised uptake values.
Intensity of 18F-GP1 PET-CT activity in bioprosthetic aortic valve thrombus2 yearsIntensity of 18F-GP1 PET-CT activity in bioprosthetic aortic valve thrombus compared to blood pool as measured by standardised uptake values.

Secondary

MeasureTime frameDescription
18F-GP1 PET-CT bioprosthetic aortic valve uptake in patients with thrombus.2 years18F-GP1 PET-CT bioprosthetic aortic valve uptake after 3 months in patients with evidence of thrombus at baseline as measured by standardised uptake values.

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 19, 2026