Investigation of the use of a radioactive dye in the diagnosis of a build-up of protein deposits within the heart

Clinical Validation of Quantitative Flutemetamol PET/CT in Cardiac Amyloidosis

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-004627-16-FI

Enrollment

Registered

2020-10-02

Start date

2020-11-25

Completion date

Unknown

Last updated

2024-10-14

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

Conditions

Cardiac amyloidosis MedDRA version: 20.0 Level: PT Classification code 10007509 Term: Cardiac amyloidosis System Organ Class: 10007541 - Cardiac disorders

Interventions

Trade Name: Vizamyl Product Name: Vizamyl Pharmaceutical Form: Solution for injection

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Known diagnosis of cardiac amyloidosis or previously excluded cardiac amyloidosis (myocardial biopsy or non-invasive imaging). Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 10 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 40

Exclusion criteria

Exclusion criteria: Pregnancy

Design outcomes

Secondary

Measure	Time frame
Secondary end point(s): New diagnosis of heart failure Heart failure hospitalization;Timepoint(s) of evaluation of this end point: 1,3 and 5 years	—

Primary

Measure	Time frame
Main Objective: In this study we evaluate the diagnostic use of flutemetamol (Vizamyl) radioactive positron emission tomography (PET) imaging agent in the detection of cardiac amyloid disease. Vizamyl is a derivate of Thioflavin-T which is used for dying amyloid proteins for microscopy. Vizamyl is accepted for clinical use in the imaging of amyloid deposits of the brain;Secondary Objective: We evaluate the possibility of noninvasive detection of different subclasses of amyloid diseases by PET imaging of signal intensity of Vizamyl;Primary end point(s): Total mortality;Timepoint(s) of evaluation of this end point: 1,3 and 5 years	—

Measure

Time frame

Main Objective: In this study we evaluate the diagnostic use of flutemetamol (Vizamyl) radioactive positron emission tomography (PET) imaging agent in the detection of cardiac amyloid disease. Vizamyl is a derivate of Thioflavin-T which is used for dying amyloid proteins for microscopy. Vizamyl is accepted for clinical use in the imaging of amyloid deposits of the brain;Secondary Objective: We evaluate the possibility of noninvasive detection of different subclasses of amyloid diseases by PET imaging of signal intensity of Vizamyl;Primary end point(s): Total mortality;Timepoint(s) of evaluation of this end point: 1,3 and 5 years

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Countries

Finland

Contacts

Public ContactDepartment of Nuclear Medicine

Helsinki University Hospital

valtteri.uusitalo@hus.fi+35846 9211247

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026