Investigation of the use of a radioactive dye in the diagnosis of a build-up of protein deposits within the heart
| ISRCTN | ISRCTN45011896 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN45011896 |
| Secondary identifying numbers | 70233 |
- Submission date
- 05/09/2020
- Registration date
- 02/10/2020
- Last edited
- 29/09/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Cancer
Plain English summary of protocol
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
Contact information
Scientific
Vaskiniementie 1, A11
Helsinki
00200
Finland
 ORCID ID |
0000-0001-7345-7122 |
|---|---|
| Phone | +358 (0)405358011 |
| vauusi@utu.fi |
Study information
| Study design | Longitudinal observational multicenter imaging study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Longitudinal study |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Clinical validation of quantitative flutemetamol PET/CT in cardiac amyloidosis |
| Study objectives | The aim of this study is to validate flutemetamol PET for imaging of cardiac amyloidosis. |
| Ethics approval(s) | 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 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/01/2019 |
| Completion date | 31/12/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 50 |
| Key inclusion criteria | Previous clinical suspicion of cardiac amyloidosis and currently know the status of their disease (e.g. no amyloidosis, light chain disease, transthyretin) |
| Key exclusion criteria | 1. Pregnancy 2. Age below 18 years 3. Unknown cardiomyopathy |
| Date of first enrolment | 01/08/2019 |
| Date of final enrolment | 31/12/2022 |
Locations
Countries of recruitment
- Finland
Study participating centres
Haartmaninkatu 4
Helsinki
00290
Finland
Isotooppilaboratorio
Keskussairaalankatu 7
Lahti
15850
Finland
Sponsor information
Hospital/treatment centre
Haartmaninkatu 4 Rakennus 1
Helsinki
00290
Finland
| Phone | +358 (0)504271445 |
|---|---|
| antti.loimaala@hus.fi | |
| Website | http://www.hus.fi/en/Pages/default.aspx |
"ROR" |
https://ror.org/02e8hzf44 |
Funders
Funder type
Hospital/treatment centre
Government organisation / Local government
- Alternative name(s)
- Helsinki University Central Hospital, HUS
- Location
- Finland
No information available
Government organisation / For-profit companies (industry)
- Alternative name(s)
- Nycomed Amersham
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/12/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in high-impact peer-reviewed cardiology journal. |
| IPD sharing plan | 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. |
Editorial Notes
23/09/2020: Trial’s existence confirmed by GE Healthcare.
