Actively Recruiting
Test-retest Study With [18F]FBB in Cardiac Amyloidosis
Led by Life Molecular Imaging GmbH · Updated on 2026-04-08
15
Participants Needed
2
Research Sites
45 weeks
Total Duration
On this page
Sponsors
L
Life Molecular Imaging GmbH
Lead Sponsor
P
pharmtrace
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Test-retest Study With [18F]FBB in Cardiac Amyloidosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 40 years or older
- Able to understand, sign, and date written informed consent
- Female subjects must be surgically sterile or post-menopausal for at least 1 year, or use effective contraception if of childbearing potential
- Male subjects and their partners of childbearing potential must use highly effective contraception for 90 days after each PET scan
- Male subjects must not donate sperm for 90 days after each PET scan
- Stable dosage regimen for medications treating multiple myeloma, chronic heart diseases, or tafamides
- Stable coagulation if arterial blood sampling is performed
- Patients with diagnosed cardiac AL amyloidosis or ATTR amyloidosis according to diagnostic criteria
- Control patients without heart failure and no suspicion of cardiac amyloidosis, or with impaired heart function but cardiac amyloidosis ruled out, or with plasma cell dyscrasia but no cardiac amyloidosis signs
You will not qualify if you...
- Received amyloid-targeting monoclonal antibody therapy in the last 3 months or currently receiving it
- Known allergic reactions or hypersensitivity to study drug compounds
- Hemoglobin below 10 g/dL
- Severe liver impairment (AST or ALT greater than 5 times upper limit normal; bilirubin greater than 3 times upper limit normal)
- Receiving hemodialysis or peritoneal dialysis
- Unable to lie flat for up to 60 minutes
- Pregnant, lactating, or breastfeeding
- Unwilling or unable to cooperate with study procedures
- Received a PET scan within one week before the [18F]florbetaben PET scan
- Contraindication to arterial cannulation if arterial sampling is performed, including allergy to local anesthetics, peripheral vascular disease, Raynaud's phenomenon, or abnormal coagulation profile
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Royal Free Hospital
London, United Kingdom, NW3 2QG
Actively Recruiting
2
King's College London
London, United Kingdom, SE1 7EH
Actively Recruiting
Research Team
I
Iris Hardewig, Dr
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here