Plain English Summary
Background and study aims
Cardiac amyloidosis is a disease in which proteins accumulate in the heart muscle resulting in loss of its function. In this study, we evaluate a commercially available radioactive imaging compound (Flutemetamol), that has been designed to stick to these accumulated proteins, in the diagnosis of cardiac amyloid disease. Flutemetamol is currently used in the imaging of Alzheimer’s disease, to detect protein accumulation in the brain. In this study, we will assess the safety and effectiveness of using Flutemetamol to detect cardiac amyloidosis.
Who can participate?
Participants are recruited from participating study centers in Finland. The requirement for participation is previously diagnosed or excluded cardiac amyloidosis.
What does the study involve?
Participants will undergo imaging of the heart using positron emission tomography (PET) imaging. Radioactive dye (Vizamyl) is administrated intravenously to arm vein. Scanning takes 30 minutes. For selected patients, another 15-minute image is acquired after 1-hour.
Participants will be given the opportunity to have another imaging scan on a different day, using a different radioactive dye. There are no follow up visits. Patient records are then checked at 1, 3, and 5 years after the imaging to assess any complications arising from the use of the radioactive dye.
What are the possible benefits and risks of participating?
The study might not offer additional health benefits to individual participants.
The safety of Flutemetamol is established in previous studies and is routinely used in patient care. It’s side effects are rare and generally mild. The physician will inform each participant on possible side effects.
Where is the study run from?
Helsinki University Hospital (Finland)
When is the study starting and how long is it expected to run for?
January 2019 to December 2025
Who is funding the study?
1. Helsinki University Hospital (Finland)
2. Sakari Alhopuro Foundation (Finland)
3. Flutemetamol compound is sponsored by General Electric Healthcare (Finland)
Who is the main contact?
Dr. Valtteri Uusitalo, valtteri.uusitalo@hus.fi
Trial website
Contact information
Type
Scientific
Primary contact
Dr Valtteri Uusitalo
ORCID ID
https://orcid.org/0000-0001-7345-7122
Contact details
Vaskiniementie 1
A11
Helsinki
00200
Finland
+358 (0)405358011
vauusi@utu.fi
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
70233
Study information
Scientific title
Clinical validation of quantitative flutemetamol PET/CT in cardiac amyloidosis
Acronym
Study hypothesis
The aim of this study is to validate flutemetamol PET for imaging of cardiac amyloidosis.
Ethics approval
Approved 13/02/2020, Helsinki University Hospital district Ethical Committee (HUS ethical committee I, HUS Töölön sairaala, PL 266, 00029 HUS, Finland; +358 (0)403594618; eettiset.toimikunnat@hus.fi), ref: HUS/896/2019
Study design
Longitudinal observational multicenter imaging study
Primary study design
Observational
Secondary study design
Longitudinal study
Trial setting
Hospitals
Trial type
Diagnostic
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Cardiac amyloidosis including light chain and transthyretin amyloidosis
Intervention
The study aims to validate commercially available positron emission tomography radiotracer Flutemetamol (Vizamyl) to diagnose cardiac amyloidosis. We evaluate the difference in myocardial radiotracer kinetics and signal intensity in patients with no amyloidosis, transthyretin amyloidosis or light chain amyloidosis.
Participants for this study undergo positron emission tomography (PET) imaging. It is similar to computed tomography scanning. Radioactive dye Vizamyl is administrated intravenously to arm vein. Scanning takes 30 minutes. For selected patients, another 15-minute image is acquired at 1-hour. PET imaging is painless and doctor discusses possible side-effects of the procedure with each individual before the imaging.
The possibility to participate to further amyloid scintigraphy ("amyloid scan") imaging is offered to those individuals without previous amyloid scintigraphy. Amyloid scintigraphy is a standard procedure similar to PET imaging. It is obtained on a different day using well-established radioactive imaging dye (HMDP).
There are no further follow-up visits after the imaging. Individuals receive a summary of their imaging results by letter and can discuss the results with a principal investigator afterwards if necessary.
To assess the prognostic significance of cardiac Flutemetamol accumulation: follow-up data on diagnoses of heart failure, heart failure hospitalization and total mortality is collected from patient records and Finnish national statistical service (time points 1, 3 and 5 years).
Intervention type
Other
Phase
Drug names
Primary outcome measure
Mortality measured using records from the Finnish national statistical service database at 1, 3 and 5 years
Secondary outcome measures
1. Heart failure measured using patient records diagnoses at 1, 3 and 5 years
2. Heart failure related hospitalizations measured using patient records at 1, 3 and 5 years
Overall trial start date
01/01/2019
Overall trial end date
31/12/2025
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Previous clinical suspicion of cardiac amyloidosis and currently know the status of their disease (e.g. no amyloidosis, light chain disease, transthyretin)
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
50
Participant exclusion criteria
1. Pregnancy
2. Age below 18 years
3. Unknown cardiomyopathy
Recruitment start date
01/08/2019
Recruitment end date
31/12/2022
Locations
Countries of recruitment
Finland
Trial participating centre
Helsinki University Hospital
Meilahti Nuclear Medicine Center
Haartmaninkatu 4
Helsinki
00290
Finland
Trial participating centre
Päijät-Häme Nuclear Medicine Center
Päijät-Hämeen keskussairaala
Isotooppilaboratorio
Keskussairaalankatu 7
Lahti
15850
Finland
Sponsor information
Organisation
Helsinki University Central Hospital
Sponsor details
Haartmaninkatu 4 Rakennus 1
Helsinki
00290
Finland
+358 (0)504271445
antti.loimaala@hus.fi
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Helsingin ja Uudenmaan Sairaanhoitopiiri
Alternative name(s)
Helsinki University Central Hospital, HUS
Funding Body Type
government organisation
Funding Body Subtype
Local government
Location
Finland
Funder name
Sakari Alhopuro Foundation
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
GE Healthcare
Alternative name(s)
Funding Body Type
private sector organisation
Funding Body Subtype
For-profit companies (industry)
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Planned publication in high-impact peer-reviewed cardiology journal.
IPD sharing statement
Sharing of raw data is considered upon reasonable request. Request can be sent to the principal investigator (Dr. Valtteri Uusitalo, valtteri.uusitalo@hus.fi).
Statistical anonymized data can be shared in the case of possible research collaboration when cleared by Helsinki University Hospital ethical board. Study participants consent has not been collected for further data sharing and thus must be cleared by Helsinki University Hospital ethical board and legal counsel case-by-cases basis. Imaging data cannot be routinely shared outside our study due to legal restrictions. Data requests are considered for 3 years after the end of the study.
Intention to publish date
31/12/2023
Participant level data
Available on request
Basic results (scientific)
Publication list