ClinicalTrials.gov record NCT06790394
Test-retest Study With [18F]FBB in Cardiac Amyloidosis
A Test-retest Study to Evaluate the Reproducibility of [18F]Florbetaben PET Imaging in Patients With Cardiac Amyloidosis and Control Patients
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
This open-label Phase 1 study evaluates how reproducible [18F]florbetaben PET scans are for imaging amyloid in the heart. It enrolls people with cardiac AL amyloidosis, cardiac ATTR amyloidosis, and control patients without cardiac amyloidosis. Participants receive two 300 MBq injections and two PET scans; blood sampling and arterial sampling for invasive quantification are included for some participants.
What it is studying. The study tests how consistent measurements from [18F]florbetaben PET scans are when repeated (test-retest variability) for cardiac amyloid. It will quantify parameters linked to cardiac amyloid deposition (for example myocardial tracer retention or retention index), measure blood metabolites, compare invasive (arterial) and non-invasive ways of measuring tracer uptake, and derive kinetic measures such as net influx rate (Ki) and volume of distribution (Vd). It will also record safety and tolerability of the imaging agent.
What the researchers hope to learn. Evaluate test-retest variability of cardiac and extracardiac [18F]florbetaben uptake; compare invasive versus non-invasive quantification methods; obtain tracer kinetic measures (Ki, Vd); and assess safety and tolerability of [18F]florbetaben.
What this study is about
The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.
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.
Interventions being studied
Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.
- Drug
- Florbetaben F18
Eligibility
The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.
Inclusion criteria
- Inclusion criteria (for all subjects):
- 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
- 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.
- Inclusion criteria for AL-CA and ATTR-CA patients:
- Patients with a clinical diagnosis of cardiac AL amyloidosis or cardiac ATTR diagnosis according to diagnostic criteria
- Inclusion criteria for control patients:
- 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
Exclusion criteria
- 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
- 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.
Study description and what participation involves
The registry record has no detailed description beyond the summary above.
AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
Participants will receive two [18F]florbetaben PET scans (a baseline scan and a repeat scan) with two tracer injections (300 MBq each) to evaluate test‑retest imaging. Study visits include blood sampling to measure metabolites and, for some participants, arterial blood sampling (an invasive procedure) to compare invasive and non‑invasive measurements; scans require lying flat for up to about 60 minutes. Safety monitoring and collection of any adverse events will occur, and participants taking multiple myeloma or chronic heart medications or tafamidis must remain on a stable dose. The total time in the study for a participant may be up to 73 days.
How the study is structured. Interventional, open-label, single-group Phase 1 diagnostic study. All participants receive two administrations of [18F]florbetaben (300 MBq) with a baseline PET scan and a repeat PET scan to assess test-retest imaging characteristics. Some participants will have blood tests and arterial sampling for invasive quantification. There is no masking or randomized comparison group.
Questions you could ask
These questions are suggestions for a conversation with the study team or your own clinician, not advice.
- This is an early-phase study, mainly about safety and dose. What is already known about this treatment?
- The listed sites are in United Kingdom. Is any of them reachable for me, and does the study help with travel?
- Which of the eligibility criteria would need to be checked with tests before I could join?
More on wild-type ATTR amyloidosis
This trial is also listed on this site under ATTRv amyloidosis.
Important dates
- Study start
- Oct 21, 2025
- Primary completion
- September 2026 (estimated)
- Study completion
- September 2026 (estimated)
- Target enrollment
- 15 participants (estimated)
- Last updated on registry
- Aug 3, 2026
- Data verified
- Oct 10, 2026
Sponsor and research team
The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.
- Lead sponsor
- Lantheus Germany GmbH
- Collaborators
- pharmtrace
Central study contact
If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.
- Sónia Alves 📞 004930461124660 ✉ lifemi-cati@lantheus.onmicrosoft.com
Participating sites (2)
- Royal Free HospitalRecruiting
London, NW3 2QG · United Kingdom
- King's College LondonCompleted
London, SE1 7EH · United Kingdom
Terms used on this page · explanations by MedicalUpdates.ai
- open-label
- No masking is used, so the assigned intervention is not deliberately hidden from participants or study staff.
- PET
- A scan in which a small amount of a radioactive tracer is injected so that activity in tissues can be seen. Often combined with a CT or MRI scan.
- Inclusion criteria
- The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
- written informed consent
- The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
- childbearing potential
- Studies often ask participants who could become pregnant, or could father a child, to use contraception during the study and for a period afterwards, because the effect of the treatment on a pregnancy is unknown.
- echocardiography
- An ultrasound scan of the heart. A transesophageal echocardiogram is done through a probe passed into the food pipe for a closer view.
- biopsy
- Removal of a small piece of tissue so it can be examined under a microscope. 'Biopsy-proven' or 'histologically confirmed' means the diagnosis was confirmed by examining tissue under a microscope.
- study drug
- A treatment that is being tested and has not been approved for this use. It may be approved for a different condition. Being studied does not mean it works or is available outside the study.
- x ULN
- The highest value of a blood test that a laboratory considers normal. Criteria such as '≤ 3 × ULN' mean the result must be no more than three times that value.
- contraindication
- A reason a particular test or treatment should not be used for a person, for example a metal implant that rules out an MRI scan.
- at screening
- The checks done before enrolment to see whether a person qualifies, such as tests, scans or a review of medical history.
- Exclusion Criteria
- The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.
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