Cardiac AmyloidosisPhase 1CATINCT06790394
Test-retest Study With [18F]FBB in Cardiac Amyloidosis
A Phase 1 study testing Florbetaben F18 in people with Cardiac Amyloidosis, run by Lantheus Germany GmbH at 2 sites in United Kingdom.
Trial summary
This study is an open-label study to evaluate and characterize test-retest reliability of [18F]florbetaben PET in subjects with AL-CA and ATTR-CA compared to non-CA subjects. Quantification of the [18F]florbetaben parameters related to the deposition of amyloid in the heart (such as Myocardial Tracer Retention (MTR)… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Cardiac Amyloidosis
- What is being tested?
- Florbetaben F18
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 21 Oct 2025to 7 Oct 2026
- Phase
- Phase 1
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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and females aged ≥40 years
- Able to understand, sign, and date written informed consent
- Written informed consent must be obtained before any assessment is performed
- 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 one week after 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, bilateral tubal occlusion, vasectomised partner or sexual 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 each PET scan (including, for female partners of childbearing potential, 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, bilateral 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
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- Medications taken for treatment of multiple myeloma or chronic diseases of the heart or tafamides treatment are maintained on a stable dosage regimen.
- Patients on stable coagulation, if arterial blood sampling isperformed.
- Patients with a clinical diagnosis of cardiac AL amyloidosis or cardiac ATTR diagnosis according to diagnostic criteria
- The control subjects must meet one of the following criteria:
- Patients without heart failure and no suspicion of cardiac amyloidosis OR
- Patients with impaired heart function but cardiac amyloidosis ruled out by echocardiography, CMR or cardiac biopsy OR
- Patients with known plasma cell dyscrasia (MGUS, multiple myeloma) but no clinical signs of cardiac amyloidosis detected by echocardiography or CMR
Who cannot join
- Subject has received, in the last 3 months, or currently receives amyloid targeting monoclonal antibody therapy.
- Any known allergic reactions or hypersensitivity towards any compound of the study drug
- Hemoglobin value < 10 g/dL
- Severe hepatic impairment (AST or ALT >5 x ULN; bilirubin >3 x ULN)
- Subject receives hemodialysis or peritoneal dialysis
- Inability to lay flat for up to 60 min
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- Pregnant, lactating or breastfeeding
- Unwilling and/or unable to cooperate with study procedures
- Having received a PET scan within one week before the 18F]florbetaben PET scan
- For patients were arterial sampling isperformed: Subject has a contraindication to arterial cannulation, including but not limited to allergy to local anesthetics, peripheral vascular disease, Raynaud's phenomenon as determined by abnormal Allen's test or abnormal coagulation profile at screening.
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Royal Free Hospital
London, NW3 2QG
King's College London
London, SE1 7EH
About this study
Official title: A Test-retest Study to Evaluate the Reproducibility of [18F]Florbetaben PET Imaging in Patients With Cardiac Amyloidosis and Control Patients
This study is an open-label study to evaluate and characterize test-retest reliability of [18F]florbetaben PET in subjects with AL-CA and ATTR-CA compared to non-CA subjects. Quantification of the [18F]florbetaben parameters related to the deposition of amyloid in the heart (such as Myocardial Tracer Retention (MTR) or Retention Index (RI)), and the variability in these parameters after repeated imaging will be evaluated. Measurement of blood metabolites and comparison of invasive with non-invasive quantification of [18F]florbetaben uptake in the heart will be performed.
- Conditions
- Cardiac Amyloidosis
- Being tested
- Florbetaben F18
- 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.
Florbetaben F18Drug
Florbetaben F18 is a radioactive diagnostic agent being developed for the indication of PET imaging of the heart to detect amyloid pathology. All patients will receive two administrations of Florbetaben F18 at a radioactive dose of 300 megabecquerel (MBq).
| Study group | Role | What they receive |
|---|---|---|
| Patients with cardiac disease | Experimental | All eligible AL, ATTR and non-CA patients will receive two injections of the investigational imaging agent florbetaben: at a baseline PET imaging session and at a follow-up PET imaging session to evaluate the test-retest imaging characteristics. 5 patients of each group will be required. Receives: Drug: Florbetaben F18 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Test-Retest variability of cardiac [18F]florbetaben PET uptake
Percent Test-Retest variability (%) of cardiac 18F florbetaben PET
Measured: The duration of the study for participants may be up to 73 days.
Secondary outcomes (4)
Test-Retest variability of extracardiac [18F]florbetaben uptake
Percent Test-Retest variability (%) of extracardiac 18F forbetaben PET
Measured: The duration of the study for participants may be up to 73 days.
Net influx rate derived from full tracer kinetic modelling
Net influx rate Ki [ml/cm3/min]
Measured: The duration of the study for participants may be up to 73 days.
Volume of distribution derived from full tracer kinetic modelling
Volume of distribution Vd
Measured: The duration of the study for participants may be up to 73 days.
Safety and tolerability of [18F]florbetaben
Number of participants with treatment-related adverse events as assessed by CTCAE version 5.0.
Measured: The duration of the study for participants may be up to 73 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2025
- Study start21 Oct 2025
- Primary completion7 Oct 2026
- Study completion7 Oct 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 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lantheus Germany GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- pharmtrace
- Responsible party
- Sponsor
- Investigators
- Andrew Stephens, MD, PhD, Study director, Lantheus Germany GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06790394
- Sponsor's protocol ID
- FBB-02-01-24
- Acronym
- CATI
- Status last verified
- Oct 2026
- First submitted
- 19 Dec 2024
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No