Cardiac AmyloidosisPhase 4NCT03040427

The Role of F-18 Florbetapir in the Early Detection of Cardiac Amyloidosis

A Phase 4 study testing F-18 florbetapir in people with Cardiac Amyloidosis, run by The Cleveland Clinic at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

The investigators postulate that F-18 florbetapir will show improved detection of cardiac amyloidosis over conventional non-invasive imaging techniques, particularly in early disease. Read more about this study

Who is it for?: Ages 18 to 95 years
Conditions the study is for: Cardiac Amyloidosis
What is being tested?: F-18 florbetapir
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 12 participants
Where: 1 siteUnited States
Study dates: Jan 2017to 21 Aug 2019
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 to 95 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients with extra-cardiac biopsy-proven AL or ATTR amyloidosis
Patients with a ratio of affected to unaffected free light chains >5 or free light chain difference of >50

Who cannot join

Echocardiographic evidence of cardiac amyloidosis with septal and posterior wall thickness ≥ 13mm
Contraindication to florbetapir or its components
Refusal to participate in the study

Trial locations and contacts

1 site in 1 country.

United States1 site

Cleveland Clinic Foundation (Main Campus)
Cleveland, Ohio, 44195

Other trials in United States

About this study

The investigators postulate that F-18 florbetapir will show improved detection of cardiac amyloidosis over conventional non-invasive imaging techniques, particularly in early disease.

Read the detailed description

F-18 florbetapir is currently used for the early detection of brain amyloid (Alzheimer's disease). The hypothesis is that F-18 florbetapir will detect amyloid deposition in myocardium prior to current non-invasive diagnostic measures, particular electrocardiography with strain and technetium pyrophosphate scintigraphy. The investigators intend to use F-18 florbetapir and assess its correlation between standard non-invasive diagnostic modalities.

Conditions: Cardiac Amyloidosis
Being tested: F-18 florbetapir
Keywords: F-18 florbetapir, Amyvid, PET scan, Early detection
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.

F-18 florbetapirDrug
Also called Amyvid, Florbetapir-fluorine-18, 18F-AV-45
Cardiac PET images will be obtained following injection of F-18 labeled Florbetapir (Trade Name: Amyvid).

Study groups in NCT03040427
Study group	Role	What they receive
AL or TTR type amyloidosis	Experimental	The participants will undergo F-18 florbetapir PET scan. Receives: Drug: F-18 florbetapir

What is being measured

The primary outcome is the main question the study is designed to answer.

Quantitative Myocardial F18-florbetapir Uptake
Number of participants with quantitative F18-florbetapir uptake above previously defined control values
Measured: at the time of the PET scan

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 201721 Aug 2019

First posted2 Feb 2017 (estimated)
Study startJan 2017
Primary completion21 Aug 2019
Study completion21 Aug 2019

Why it stopped: Low enrollment

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Cardiac AmyloidosisStudies of the same condition, open and under way.
More trials run by The Cleveland ClinicThe 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: Phase 4
Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 12 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03040427
Sponsor's protocol ID: 16-960
Status last verified: Jul 2021
First submitted: 31 Jan 2017
Last updated: 27 Jul 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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

All Cardiac Amyloidosis trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Role of F-18 Florbetapir in the Early Detection of Cardiac Amyloidosis
ClinicalTrials.gov ID: NCT03040427
Acronym / sponsor ID: 16-960
Conditions: Cardiac Amyloidosis
Keywords: F-18 florbetapir, Amyvid, PET scan, Early detection
Phase: Phase 4
Study type: Interventional
Recruitment status: TerminatedReason stopped: Low enrollment
Enrolment: 12 participants (actual)
Lead sponsor: The Cleveland ClinicUniversity, hospital or other
Collaborators: Avid Radiopharmaceuticals
Study start: Jan 2017 (actual)
Primary completion: 21 Aug 2019 (actual)
Study completion: 21 Aug 2019 (actual)
First posted: 2 Feb 2017 (estimated)
Results: Posted 27 Jul 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The investigators postulate that F-18 florbetapir will show improved detection of cardiac amyloidosis over conventional non-invasive imaging techniques, particularly in early disease.

Detailed description

Study design

Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
AL or TTR type amyloidosis	Experimental	Drug: F-18 florbetapirThe participants will undergo F-18 florbetapir PET scan.

Who may qualify

Ages: 18 to 95 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Patients with extra-cardiac biopsy-proven AL or ATTR amyloidosis
Patients with a ratio of affected to unaffected free light chains >5 or free light chain difference of >50

Key exclusion criteria (3 listed)

Echocardiographic evidence of cardiac amyloidosis with septal and posterior wall thickness ≥ 13mm
Contraindication to florbetapir or its components
Refusal to participate in the study

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
F-18 florbetapirAlso: Amyvid, Florbetapir-fluorine-18, 18F-AV-45Cardiac PET images will be obtained following injection of F-18 labeled Florbetapir (Trade Name: Amyvid).	Drug	AL or TTR type amyloidosis

Primary outcome

Quantitative Myocardial F18-florbetapir Uptake
Time frame: at the time of the PET scan
Number of participants with quantitative F18-florbetapir uptake above previously defined control values

Results and safety

Results posted to the registry on 27 Jul 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
At Risk for Symptomatic AL Cardiac Amyloidosis	2	2
At Risk for Symptomatic ATTR Cardiac Amyloidosis	6	6
Control Patients	4	4

Primary outcome: Quantitative Myocardial F18-florbetapir Uptake

Time frame: at the time of the PET scan. Count of participants. Unit: Participants

Measure	At Risk for Symptomatic AL Cardiac Amyloidosis n = 2	At Risk for Symptomatic ATTR Cardiac Amyloidosis n = 6	Control Patients n = 4
Value	2	6	4

Population analysed: All participants had quantitative uptake of F18-Flobetapir

Adverse events

Time frame: 24 hours. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
At Risk for Symptomatic AL Cardiac Amyloidosis	0 of 2 (0%)	0 of 2 (0%)	0 of 2
At Risk for Symptomatic ATTR Cardiac Amyloidosis	0 of 6 (0%)	0 of 6 (0%)	0 of 6
Control Patients	0 of 4 (0%)	0 of 4 (0%)	0 of 4

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.

Steven Nissen, MD study chair

The Cleveland Clinic

Wael Jaber, MD principal investigator

The Cleveland Clinic

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing F-18 florbetapir in people with Cardiac Amyloidosis, run by The Cleveland Clinic at 1 site in United States.

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 2 inclusion and 3 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 27 Jul 2021. 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 United States. 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?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Jul 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Quantitative Myocardial F18-florbetapir Uptake (time frame: at the time of the PET scan). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03040427.

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 27 Jul 2021.