At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Florbetaben F18 (drug)
- How long the study runs
- Study runs about 11 months (dates as stated)
- About the drug or intervention
- Florbetaben F18 — drug: Florbetaben F18 is a radioactive diagnostic agent being developed for the indication of PET imaging of the heart to detect amyloid pathology.
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 40 Years and over
- Who
- All
- Number of participants
- 15
- Started
- 2025-10-21
- Last checked
- 2026-07
Plain English Summary
What is this study?
- • Testing a new treatment for cardiac amyloidosis
- • Phase1 - 15 participants
- • 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
Who can take part?
- • Ages 40 Years and over
- • Diagnosed with cardiac amyloidosis
Where?
- • London - Royal Free Hospital
- • London - King's College London
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 40 Years and over
- Who can join: All genders
What the study is looking for
- ✓Inclusion criteria (for all subjects):
- ✓Males and females aged ≥40 years
- ✓Able to understand, sign, and date written agreement to take part
- ✓Written agreement to take part must be obtained before any assessment is performed
- ✓Male subjects must commit to not donate sperm for a minimum of 90 days after the PET scan
Who cannot take part
- ✗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 the study treatment
- ✗red blood cell level value \< 10 g/dL
- ✗Severe liver impairment (liver enzymes or liver enzymes \>5 x ULN; liver blood test \>3 x ULN)
- ✗Subject receives hemodialysis or peritoneal dialysis
See the full criteria
Where Is This Study? (2 UK sites)
Royal Free Hospital
London NW3 2QG, United Kingdom
King's College London
London SE1 7EH, United Kingdom
How to Get in Touch
Sónia Alves
Sponsor contactCONTACT
