Cardiac AmyloidosisEarly Phase 1AMYLCARNCT03232632
Assessment of Cardiac Fixation During PET Using a New Drug Within Amyloid Cardiac Injuries.
A Early Phase 1 study testing PET with 18 F-Flutemetamol in people with Cardiac Amyloidosis, run by University Hospital, Toulouse at 1 site in France.
Trial summary
To estimate distribution's parameters of 18F-Flutemetamol (Vizamyl®) fixation on myocardium for patients with amyloid cardiac injuries. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Amyloidosis
- What is being tested?
- PET with 18 F-Flutemetamol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteFrance
- Study dates
- 15 Mar 2017to 15 Sep 2019
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients followed for amyloidosis with proved cardiac injury or strongly suspected:
- cardiac echography with typical signs of amyloid injury,
- anatomical result confirming presence of amyloid deposits at cardiac or peripheral level
- Signature of Informed Consent Form,
- Affiliation to a social security system
Who cannot join
- Patient who suffers from another pathology which could lead cardiac injury (coronary disease, valvular disease, other pathology of deposit),
- Pregnancy and lactating women,
- Absence of effective contraception,
- Irradiating examination performed within the last 12 months or scheduled within the next 12 months,
- Unable patient physically, mentally or legally to provide informed consent,
- Patient under a system of legal protection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Cardiac Fixation During Positron Emission Tomography (PET) Examination Using 18F-Flutemetamol (Vizamyl ®) Within Amyloid Cardiac Injuries.
To estimate distribution's parameters of 18F-Flutemetamol (Vizamyl®) fixation on myocardium for patients with amyloid cardiac injuries.
Read the detailed description
Hypothesis had been performed that PET with 18F-Flutemetamol (Vizamyl®) could lead an early diagnostic. Indeed, this tracer had been recently used to highlight inter-cerebral beta-amyloid plaques on patients with Alzheimer Disease.
Because this labelling is performed on amyloid deposits, this tracer would lead to view and to quantify amyloid deposits within cardiac amyloid injuries.
Results of this PET will be combined with scan examinations for a better anatomic tracking.
- Conditions
- Cardiac Amyloidosis
- Being tested
- PET with 18 F-Flutemetamol
- Medical subject headings
- Amyloid Neuropathies, Familial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET with 18 F-FlutemetamolDrug
Also called Vizamyl®
PET with 18 F-Flutemetamol (Vizamyl ®)
| Study group | Role | What they receive |
|---|---|---|
| PET with 18 F-Flutemetamol | Experimental | PET with 18 F-Flutemetamol (Vizamyl®) = product under Alzheimer's disease indication Receives: Drug: PET with 18 F-Flutemetamol |
What is being measured
The primary outcome is the main question the study is designed to answer.
ratio Heart/ Upper Mediastinum
peak of 18F-Flutemetamol capture
Measured: average of last 15 minutes
standardized uptake value (SUV) measures
standardized uptake value (SUV) measures
Measured: average of last 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2017
- Study start15 Mar 2017
- Primary completion15 Sep 2019
- Study completion15 Sep 2019
Why it stopped: intervention programming
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac AmyloidosisStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eric OUHAYOUN, MD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03232632
- Sponsor's protocol ID
- 13 199 02
- Acronym
- AMYLCAR
- Status last verified
- Aug 2020
- First submitted
- 11 Jan 2017
- Last updated
- 26 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Cardiac Fixation During Positron Emission Tomography (PET) Examination Using 18F-Flutemetamol (Vizamyl ®) Within Amyloid Cardiac Injuries.
- ClinicalTrials.gov ID
- NCT03232632
- Acronym / sponsor ID
- AMYLCAR / 13 199 02
- Conditions
- Cardiac Amyloidosis
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: intervention programming
- Enrolment
- 7 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 15 Mar 2017 (actual)
- Primary completion
- 15 Sep 2019 (actual)
- Study completion
- 15 Sep 2019 (actual)
- First posted
- 28 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To estimate distribution's parameters of 18F-Flutemetamol (Vizamyl®) fixation on myocardium for patients with amyloid cardiac injuries.
Detailed description
Hypothesis had been performed that PET with 18F-Flutemetamol (Vizamyl®) could lead an early diagnostic. Indeed, this tracer had been recently used to highlight inter-cerebral beta-amyloid plaques on patients with Alzheimer Disease.
Because this labelling is performed on amyloid deposits, this tracer would lead to view and to quantify amyloid deposits within cardiac amyloid injuries.
Results of this PET will be combined with scan examinations for a better anatomic tracking.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PET with 18 F-Flutemetamol | Experimental | Drug: PET with 18 F-FlutemetamolPET with 18 F-Flutemetamol (Vizamyl®) = product under Alzheimer's disease indication |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients followed for amyloidosis with proved cardiac injury or strongly suspected:
- Signature of Informed Consent Form,
- Affiliation to a social security system
Key exclusion criteria (6 listed)
- Patient who suffers from another pathology which could lead cardiac injury (coronary disease, valvular disease, other pathology of deposit),
- Pregnancy and lactating women,
- Absence of effective contraception,
- Irradiating examination performed within the last 12 months or scheduled within the next 12 months,
- Unable patient physically, mentally or legally to provide informed consent,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PET with 18 F-FlutemetamolAlso: Vizamyl®PET with 18 F-Flutemetamol (Vizamyl ®) | Drug | PET with 18 F-Flutemetamol |
Primary outcome
ratio Heart/ Upper Mediastinum
Time frame: average of last 15 minutes
peak of 18F-Flutemetamol capture
standardized uptake value (SUV) measures
Time frame: average of last 15 minutes
standardized uptake value (SUV) measures
Results and safety
The study was stopped early (reason given: intervention programming). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2020.
- Individual participant dataSharing planned: No
Related trials for Cardiac Amyloidosis
Active, not recruitingObservational study
A Retrospective Observational Study of Epidemiology and Outcomes in Transthyretin Amyloid Cardiomyopathy in Germany
ATTR-CM (Transthyretin Amyloid Cardiomyopathy)
Active, not recruitingPhase 3
EPIC-ATTR: A Study to Evaluate the Effect of Eplontersen on the Transthyretin Reduction and Long-term Safety in Chinese Subjects With Transthyretin Amyloid Cardiomyopathy
Transthyretin Amyloid Cardiomyopathy
RecruitingObservational study
Essen Amyloidosis Registry
Amyloidosis; Systemic, Amyloidosis Cardiac
Active, not recruitingPhase 3
A Phase 3 Study of NTLA-2001 in ATTRv-PN
Neuromuscular Disease, Neuromuscular Diseases (NMD)
RecruitingPhase 3
MAGNITUDE: A Phase 3 Study of NTLA-2001 in Participants With Transthyretin Amyloidosis With Cardiomyopathy (ATTR-CM)
Transthyretin Amyloidosis (ATTR) With Cardiomyopathy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric OUHAYOUN, MD principal investigator
University Hospital, Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing PET with 18 F-Flutemetamol in people with Cardiac Amyloidosis, run by University Hospital, Toulouse at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 26 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: intervention programming). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ratio Heart/ Upper Mediastinum (time frame: average of last 15 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2020; AzTrials last refreshed its copy on 7 Nov 2026.