Test-retest with 18F-florbetaben in cardiac amyloidosis
A Test-retest Study to Evaluate the Reproducibility of [18F]Florbetaben PET Imaging in Patients With Cardiac Amyloidosis and Control Patients
We will test whether repeated 18F-florbetaben PET scans give consistent measurements of heart amyloid in people with AL or ATTR cardiac amyloidosis and in people without cardiac amyloid.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Ages | 40 Years and up |
| Sex | All |
| Sponsor | Life Molecular Imaging SA Industry-sponsored |
| Locations | 2 sites (London and 1 other locations) |
| Trial ID | NCT06790394 on ClinicalTrials.gov |
What this trial studies
This open-label phase 1 protocol performs repeat 18F-florbetaben PET imaging to characterize test-retest reliability of myocardial tracer retention (MTR) and retention index (RI) in participants with AL and ATTR cardiac amyloidosis and in non-amyloid controls. Participants will undergo two PET sessions with blood sampling for metabolite analysis and, where applicable, comparison of invasive versus non-invasive quantification of tracer uptake. The study quantifies variability in PET-derived parameters after repeated imaging to determine precision and reproducibility. Results are intended to inform the use of florbetaben PET for measuring cardiac amyloid burden in clinical care and future trials.
Who should consider this trial
Good fit: Ideal candidates are adults aged 40 or older with diagnosed AL or ATTR cardiac amyloidosis, or matched non-amyloid controls, who can give informed consent, attend repeat PET scans, and undergo blood sampling while meeting contraception and safety requirements.
Not a fit: People who cannot undergo PET imaging or blood draws, are pregnant, or do not have confirmed cardiac amyloidosis are unlikely to receive direct benefit from this imaging-focused study.
Why it matters
Potential benefit: If successful, this could make florbetaben PET a more reliable tool for measuring cardiac amyloid burden, improving diagnosis, monitoring, and the design of treatment trials.
How similar studies have performed: Florbetaben and other amyloid PET tracers have shown promising detection of cardiac amyloid in prior work, but rigorous test-retest reliability data for cardiac applications are still limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
London and 1 other locations
- Royal Free Hospital — London, United Kingdom (Recruiting)
- King's College London — London, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Iris Hardewig, Dr
- Email: CATI@life-mi.com
- Phone: 004930461124660
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.