Actively Recruiting
Efficacy of [18F]Florbetaben PET for Diagnosis of Cardiac AL Amyloidosis
Led by Life Molecular Imaging GmbH · Updated on 2025-11-25
200
Participants Needed
14
Research Sites
163 weeks
Total Duration
On this page
Sponsors
L
Life Molecular Imaging GmbH
Lead Sponsor
P
pharmtrace klinische Entwicklung GmbH
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is an open-label, multi-center pivotal Phase 3 study to visually and quantitatively assess PET images obtained after single application of 300 MBq \[18F\]florbetaben and PET scanning of patients with suspected cardiac amyloidosis.
CONDITIONS
Official Title
Efficacy of [18F]Florbetaben PET for Diagnosis of Cardiac AL Amyloidosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18 years or older
- Able to understand and sign written informed consent
- Suspected cardiac amyloidosis based on either systemic amyloidosis without confirmed heart involvement, known plasma cell dyscrasia, abnormal free light chain levels, or heart failure with preserved ejection fraction
- Evidence of cardiac involvement shown by left ventricular wall thickness over 12 mm without other cause or elevated NT-proBNP (>335 ng/L) or BNP (>81 ng/L)
- Planned diagnostic procedures like biopsy combined with cardiac imaging
- Female participants must be surgically sterile, post-menopausal for at least 1 year, or use highly effective contraception for at least one week after PET scan
- Male participants and their partners of childbearing potential must use highly effective contraception for at least 90 days after PET scan
- Male participants must agree not to donate sperm for 90 days after PET scan
You will not qualify if you...
- Known allergy or hypersensitivity to any component of the study drug
- Severe liver impairment (AST/ALT >5 times upper limit of normal; bilirubin >3 times upper limit of normal)
- Unable to lie flat for up to 60 minutes
- Pregnant, breastfeeding, or lactating
- Unwilling or unable to cooperate with study procedures
- Received radiopharmaceuticals within 10 radioactive half-lives before study drug administration
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 14 locations
1
St Luke's Hospital
Kansas City, Kansas, United States, 64111
Actively Recruiting
2
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
3
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
Actively Recruiting
4
University of Augsburg
Augsburg, Germany, 86156
Actively Recruiting
5
Charite Berlin
Berlin, Germany, 13353
Actively Recruiting
6
University of Essen
Essen, Germany, 45147
Actively Recruiting
7
HOPA Hamburg
Hamburg, Germany, 22767
Actively Recruiting
8
University of Heidelberg
Heidelberg, Germany, 69120
Actively Recruiting
9
University of Würzburg
Würzburg, Germany, 97080
Actively Recruiting
10
Hospital University Bellvitge
Barcelona, Spain, 08907
Actively Recruiting
11
Hospital University Puerta de Hierro
Madrid, Spain, 28222
Actively Recruiting
12
Clínica Universidad de Navarra
Pamplona, Spain, 31008
Actively Recruiting
13
University of Salamanca
Salamanca, Spain, 37007
Actively Recruiting
14
Royal Free Hospital
London, United Kingdom, NW3 2PF
Actively Recruiting
Research Team
I
Iris Hardewig, PhD
CONTACT
A
Aleksandar Jovalekic, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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