Efficacy of [18F]Florbetaben PET for Diagnosis of Cardiac AL Amyloidosis
NCT ID: NCT05184088
Last Updated: 2025-11-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
200 participants
INTERVENTIONAL
2023-01-13
2026-03-31
Brief Summary
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Detailed Description
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The diagnostic efficacy of the visual and quantitative assessments of \[18F\]florbetaben PET images for diagnosis of cardiac AL Amyloidosis will be determined by comparison to the standard of truth (SoT) obtained through standard of care clinical diagnosis.
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Patients with suspected cardiac amyloidosis
After enrolment, patients will be subjected to diagnostic procedures according to standard of care to resolve diagnostic uncertainties and to clarify possible cardiac involvement. The results of the clinical work-up will be used a standard of truth, i.e. patients with initially suspected cardiac amyloidosis that where subsequently clinically diagnosed with cardiac AL Amyloidosis, cardiac ATTR Amyloidosis, other cardiac Amyloidosis or non cardiac amyloidosis.
[18F]florbetaben
All enrolled patients will undergo \[18F\]florbetaben PET imaging.
Interventions
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[18F]florbetaben
All enrolled patients will undergo \[18F\]florbetaben PET imaging.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Able to understand, sign and date written informed consent
* Written informed consent must be obtained before any study procedures are performed
* Subjects being considered for a possible diagnosis of cardiac amyloidosis by
* 1\. One of the following conditions:
* Established systemic amyloidosis without proven cardiac involvement,
* Known plasma cell dyscrasia (MGUS, multiple myeloma),
* Pathological free light chain levels in urine or serum,
* Presence of heart failure with preserved ejection fraction
* 2\. AND one of the following parameters, indicative of cardiac manifestation:
* Mean (left ventricular (LV) wall + septum) thickness \>12mm as measured by echocardiography or CMR in absence of other known cause of left ventricular hypertrophy (LVH),
* NT-proBNP \>335 ng/L (in case a value for NT-proBNP is not available, BNP \> 81ng/L may be used instead)
* Planned diagnostic procedure to establish diagnosis and cardiac involvement (e.g., endomyocardial biopsy or extracardiac biopsy in conjunction with cardiac magnetic resonance imaging/echocardiography or bone scintigraphy)
* 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 at least one week following 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, bilaterial tubal occlusion, vasectomised parner or secual 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 the PET scan (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, bilaterial 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
Exclusion Criteria
* Severe hepatic impairment (AST/ALT \>5 x ULN; bilirubin \>3 x ULN)
* Inability to lay flat for up to 60 min
* Pregnant, lactating or breastfeeding
* Unwilling and/or unable to cooperate with study procedures
* Having been administered a radiopharmaceutical within 10 radioactive half-lives prior to study drug administration in this study
18 Years
ALL
No
Sponsors
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pharmtrace klinische Entwicklung GmbH
UNKNOWN
Life Molecular Imaging GmbH
INDUSTRY
Responsible Party
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Principal Investigators
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Andrew Stephens, MD, PhD
Role: STUDY_DIRECTOR
Life Molecular Imaging
Locations
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St Luke's Hospital
Kansas City, Kansas, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, United States
University of Augsburg
Augsburg, , Germany
Charite Berlin
Berlin, , Germany
University of Essen
Essen, , Germany
HOPA Hamburg
Hamburg, , Germany
University of Heidelberg
Heidelberg, , Germany
University of Würzburg
Würzburg, , Germany
Hospital University Bellvitge
Barcelona, , Spain
Hospital University Puerta de Hierro
Madrid, , Spain
Clínica Universidad de Navarra
Pamplona, , Spain
University of Salamanca
Salamanca, , Spain
Royal Free Hospital
London, , United Kingdom
Countries
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Central Contacts
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Other Identifiers
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FBB-02-01-21
Identifier Type: -
Identifier Source: org_study_id
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