Cardiac AmyloidosisPhase 3CArdiagNCT05184088
Efficacy of [18F]Florbetaben PET for Diagnosis of Cardiac AL Amyloidosis
A Phase 3 study testing [18F]florbetaben in people with Cardiac Amyloidosis and AL Amyloidosis, run by Lantheus Germany GmbH at 14 sites in 4 countries.
Trial summary
This is an open-label, multi-center pivotal Phase 3 study to visually and quantitatively assess PET images obtained after single application of 300 MBq [18F]florbetaben and PET scanning of patients with suspected cardiac amyloidosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Amyloidosis, AL Amyloidosis, ATTR Amyloidosis
- What is being tested?
- [18F]florbetaben
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 244 participants
- Where
- 14 sitesin 4 countries
- Study dates
- 13 Jan 2023to 5 May 2026
- Phase
- Phase 3
- 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
- Males and females age ≥18 years
- Able to understand, sign and date written informed consent
- Written informed consent must be obtained before any study procedures are performed
- Subjects being considered for a possible diagnosis of cardiac amyloidosis by
- 1. One of the following conditions:
- Established systemic amyloidosis without proven cardiac involvement,
Show all 16Show fewer
- Known plasma cell dyscrasia (MGUS, multiple myeloma),
- Pathological free light chain levels in urine or serum,
- Presence of heart failure with preserved ejection fraction
- 2. AND one of the following parameters, indicative of cardiac manifestation:
- Mean (left ventricular (LV) wall + septum) thickness >12mm as measured by echocardiography or CMR in absence of other known cause of left ventricular hypertrophy (LVH),
- NT-proBNP >335 ng/L (in case a value for NT-proBNP is not available, BNP > 81ng/L may be used instead)
- Planned diagnostic procedure to establish diagnosis and cardiac involvement (e.g., endomyocardial biopsy or extracardiac biopsy in conjunction with cardiac magnetic resonance imaging/echocardiography or bone scintigraphy)
- Female subjects must be documented by medical records or physician's note to be either surgically sterile (by means of hysterectomy, bilateral salpingectomy, or bilateral oophorectomy) or post-menopausal for at least 1 year (no menses for 12 months without an alternative medical cause). If they are of child-bearing potential, they must commit to use of a highly effective contraceptive measure for at least one week following the PET scan (including combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal or transdermal), progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable or implantable), intrauterine device, intrauterine hormone-releasing system, bilaterial tubal occlusion, vasectomised parner or secual abstinence).
- Male subjects and their partners of childbearing potential must commit to the use of a highly effective method of contraception for a minimum of 90 days following the PET scan (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal or transdermal), progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable or implantable), intrauterine device, intrauterine hormone-releasing system, bilaterial tubal occlusion, male subjects with vasectomy or sexual abstinence)
- Male subjects must commit to not donate sperm for a minimum of 90 days after the PET scan
Who cannot join
- Any known allergic reactions or hypersensitivity towards any compound of the study drug
- Severe hepatic impairment (AST/ALT >5 x ULN; bilirubin >3 x ULN)
- Inability to lay flat for up to 60 min
- Pregnant, lactating or breastfeeding
- Unwilling and/or unable to cooperate with study procedures
- Having been administered a radiopharmaceutical within 10 radioactive half-lives prior to study drug administration in this study
Trial locations and contacts
14 sites in 4 countries.
14 sites in 4 countries
Germany6 sites
University of Augsburg
Augsburg, 86156
Charite Berlin
Berlin, 13353
University of Essen
Essen, 45147
HOPA Hamburg
Hamburg, 22767
University of Heidelberg
Heidelberg, 69120
University of Würzburg
Würzburg, 97080
Spain4 sites
Hospital University Bellvitge
Barcelona, 08907
Hospital University Puerta de Hierro
Madrid, 28222
Clínica Universidad de Navarra
Pamplona, 31008
University of Salamanca
Salamanca, 37007
United States3 sites
St Luke's Hospital
Kansas City, Kansas, 64111
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
About this study
Official title: An Open-label, Multi-center, Non-randomized Pivotal Phase 3 Study to Evaluate the Efficacy and Safety of [18F]Florbetaben Positron Emission Tomography (PET) Imaging to Diagnose Cardiac AL Amyloidosis
This is an open-label, multi-center pivotal Phase 3 study to visually and quantitatively assess PET images obtained after single application of 300 MBq [18F]florbetaben and PET scanning of patients with suspected cardiac amyloidosis.
Read the detailed description
This is an open-label, multi-center pivotal Phase 3 study to visually and quantitatively assess PET images obtained after single application of 300 MBq [18F]florbetaben and PET scanning of patients with suspected cardiac amyloidosis or with a putative diagnosis of cardiac amyloidosis but with remaining diagnostic uncertainty (e.g., unclear etiology or cardiac manifestation) or patients with diagnosis of amyloidosis but unclear cardiac involvement.
The diagnostic efficacy of the visual and quantitative assessments of [18F]florbetaben PET images for diagnosis of cardiac AL Amyloidosis will be determined by comparison to the standard of truth (SoT) obtained through standard of care clinical diagnosis.
- Conditions
- Cardiac Amyloidosis, AL Amyloidosis, ATTR Amyloidosis
- Being tested
- [18F]florbetaben
- Keywords
- AL Amyloidosis, ATTR Amyloidosis, Cardiac Amyloidosis
- Medical subject headings
- Amyloid Neuropathies, Familial, Immunoglobulin Light-chain Amyloidosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[18F]florbetabenDrug
Also called Neuraceq
All enrolled patients will undergo [18F]florbetaben PET imaging.
| Study group | Role | What they receive |
|---|---|---|
| Patients with suspected cardiac amyloidosis | Experimental | After enrolment, patients will be subjected to diagnostic procedures according to standard of care to resolve diagnostic uncertainties and to clarify possible cardiac involvement. The results of the clinical work-up will be used a standard of truth, i.e. patients with initially suspected cardiac amyloidosis that where subsequently clinically diagnosed with cardiac AL Amyloidosis, cardiac ATTR Amyloidosis, other cardiac Amyloidosis or non cardiac amyloidosis. Receives: Drug: [18F]florbetaben |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and specificity of the visual assessment of [18F]florbetaben PET images for the diagnosis of cardiac AL amyloidosis.
The results from the visual assessment of [18F]florbetaben PET images are compared to the clinical diagnosis established through histological verification of the presence or absence of AL amyloidosis with cardiac involvement determined either through endomyocardial biopsy or through extracardiac biopsy in conjunction with typical CMR or echocardiography imaging features as the standard of truth.
Measured: Up to 12 weeks
Secondary outcomes (5)
Sensitivity and specificity of [18F]florbetaben PET for the diagnosis of cardiac AL amyloidosis using quantification.
The sensitivity and specificity of [18F]florbetaben PET for the diagnosis of cardiac AL amyloidosis will be determined by using quantitative image analysis.
Measured: Up to 12 weeks
Correlation of quantitative [18F]florbetaben PET results with left ventricular ejection fraction (LV EF) and left ventricular mass (LV mass).
Correlation of quantitative [18F]florbetaben PET results with left ventricular ejection fraction (LV EF) and left ventricular mass (LV mass).
Measured: Up to 12 weeks
Correlation of quantitative [18F]florbetaben PET results with AL CA stage I - IV based on FLC-diff, cTnT and NT-proBNP levels.
Correlation of quantitative [18F]florbetaben PET results with AL CA stage I - IV based on FLC-diff, cTnT and NT-proBNP levels.
Measured: Up to 12 weeks
Impact of PET imaging (AL-CA/non AL-CA) on diagnostic thinking and patient management will be assessed with physician's questionnaires before and after the diagnostic work-up, and after receipt of the PET results.
The impact of PET imaging (AL-CA/non AL-CA) on diagnostic thinking and patient management will be assessed with physician's questionnaires before and after the diagnostic work-up, and after receipt of the PET results.
Measured: Up to 14 weeks
Number of adverse events
Safety will be evaluated by collection of Adverse Events.
Measured: Up to 17 days after imaging visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2022
- Study start13 Jan 2023
- Primary completion21 Apr 2026
- Study completion5 May 2026
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.
- 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 3
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All eligible patients will receive a single administration of the imaging agent \[18F\]florbetaben at a radioactive dose of 300 MBq.
- Masking
- None (open label)
- Enrolment
- 244 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lantheus Germany GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- pharmtrace klinische Entwicklung GmbH
- Responsible party
- Sponsor
- Investigators
- Andrew Stephens, MD, PhD, Study director, Lantheus Germany GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05184088
- Sponsor's protocol ID
- FBB-02-01-21
- Acronym
- CArdiag
- Status last verified
- Oct 2026
- First submitted
- 6 Jan 2022
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Multi-center, Non-randomized Pivotal Phase 3 Study to Evaluate the Efficacy and Safety of [18F]Florbetaben Positron Emission Tomography (PET) Imaging to Diagnose Cardiac AL Amyloidosis
- ClinicalTrials.gov ID
- NCT05184088
- Acronym / sponsor ID
- CArdiag / FBB-02-01-21
- Conditions
- Cardiac Amyloidosis, AL Amyloidosis, ATTR Amyloidosis
- Keywords
- AL Amyloidosis, ATTR Amyloidosis, Cardiac Amyloidosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 244 participants (actual)
- Lead sponsor
- Lantheus Germany GmbHIndustry (pharma, biotech, devices)
- Collaborators
- pharmtrace klinische Entwicklung GmbH
- Study start
- 13 Jan 2023 (actual)
- Primary completion
- 21 Apr 2026 (actual)
- Study completion
- 5 May 2026 (actual)
- First posted
- 11 Jan 2022 (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.
This is an open-label, multi-center pivotal Phase 3 study to visually and quantitatively assess PET images obtained after single application of 300 MBq [18F]florbetaben and PET scanning of patients with suspected cardiac amyloidosis.
Detailed description
This is an open-label, multi-center pivotal Phase 3 study to visually and quantitatively assess PET images obtained after single application of 300 MBq [18F]florbetaben and PET scanning of patients with suspected cardiac amyloidosis or with a putative diagnosis of cardiac amyloidosis but with remaining diagnostic uncertainty (e.g., unclear etiology or cardiac manifestation) or patients with diagnosis of amyloidosis but unclear cardiac involvement.
The diagnostic efficacy of the visual and quantitative assessments of [18F]florbetaben PET images for diagnosis of cardiac AL Amyloidosis will be determined by comparison to the standard of truth (SoT) obtained through standard of care clinical diagnosis.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All eligible patients will receive a single administration of the imaging agent [18F]florbetaben at a radioactive dose of 300 MBq.
| Arm | Type | Receives |
|---|---|---|
| Patients with suspected cardiac amyloidosis | Experimental | Drug: [18F]florbetabenAfter enrolment, patients will be subjected to diagnostic procedures according to standard of care to resolve diagnostic uncertainties and to clarify possible cardiac involvement. The results of the clinical work-up will be used a standard of truth, i.e. patients with initially suspected cardiac amyloidosis that where subsequently clinically diagnosed with cardiac AL Amyloidosis, cardiac ATTR Amyloidosis, other cardiac Amyloidosis or non cardiac amyloidosis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Males and females age ≥18 years
- Able to understand, sign and date written informed consent
- Written informed consent must be obtained before any study procedures are performed
- Subjects being considered for a possible diagnosis of cardiac amyloidosis by
- 1. One of the following conditions:
Key exclusion criteria (6 listed)
- Any known allergic reactions or hypersensitivity towards any compound of the study drug
- Severe hepatic impairment (AST/ALT >5 x ULN; bilirubin >3 x ULN)
- Inability to lay flat for up to 60 min
- Pregnant, lactating or breastfeeding
- Unwilling and/or unable to cooperate with study procedures
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 |
|---|---|---|
| [18F]florbetabenAlso: NeuraceqAll enrolled patients will undergo [18F]florbetaben PET imaging. | Drug | Patients with suspected cardiac amyloidosis |
Primary outcome
Sensitivity and specificity of the visual assessment of [18F]florbetaben PET images for the diagnosis of cardiac AL amyloidosis.
Time frame: Up to 12 weeks
The results from the visual assessment of [18F]florbetaben PET images are compared to the clinical diagnosis established through histological verification of the presence or absence of AL amyloidosis with cardiac involvement determined either through endomyocardial biopsy or through extracardiac biopsy in conjunction with typical CMR or echocardiography imaging features as the standard of truth.
5 secondary outcomes
Sensitivity and specificity of [18F]florbetaben PET for the diagnosis of cardiac AL amyloidosis using quantification.
Time frame: Up to 12 weeks
Correlation of quantitative [18F]florbetaben PET results with left ventricular ejection fraction (LV EF) and left ventricular mass (LV mass).
Time frame: Up to 12 weeks
Correlation of quantitative [18F]florbetaben PET results with AL CA stage I - IV based on FLC-diff, cTnT and NT-proBNP levels.
Time frame: Up to 12 weeks
Impact of PET imaging (AL-CA/non AL-CA) on diagnostic thinking and patient management will be assessed with physician's questionnaires before and after the diagnostic work-up, and after receipt of the PET results.
Time frame: Up to 14 weeks
Number of adverse events
Time frame: Up to 17 days after imaging visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
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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.
Andrew Stephens, MD, PhD study director
Lantheus Germany GmbH
14 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing [18F]florbetaben in people with Cardiac Amyloidosis and AL Amyloidosis, run by Lantheus Germany GmbH at 14 sites in 4 countries.
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 16 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: finished, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Germany, Spain, United States, United Kingdom. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Sensitivity and specificity of the visual assessment of [18F]florbetaben PET images for the diagnosis of cardiac AL amyloidosis. (time frame: Up to 12 weeks). 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 Oct 2026.