Efficacy of [18F]Florbetaben PET for Diagnosis of Cardiac AL Amyloidosis

AL Amyloidosis Clinical Trial

— CArdiag  

Official title:

An Open-label, Multi-center, Non-randomized Pivotal Phase 3 Study to Evaluate the Efficacy and Safety of [18F]Florbetaben Positron Emission Tomography (PET) Imaging to Diagnose Cardiac AL Amyloidosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05184088
• Other study ID #: FBB-02-01-21
• Status: Recruiting
• Phase: Phase 3
• Start date: January 13, 2023
• Est. completion date: June 2025

Study information

• Verified date: April 2024
• Source: Life Molecular Imaging SA
• Contact: Iris Hardewig, PhD
• Phone: +49 (0)30 461 1246 03
• Email: clinicaltrials[@]life-mi.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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 or with a putative diagnosis of cardiac amyloidosis but with remaining diagnostic uncertainty (e.g., unclear etiology or cardiac manifestation) or patients with diagnosis of amyloidosis but unclear cardiac involvement. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: June 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Males and females age =18 years
• Able to understand, sign and date written informed consent
• Written informed consent must be obtained before any assessment is 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 in absence of other known cause of left ventricular hypertrophy (LVH),
• NT-proBNP >335 ng/L
• 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
• 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
• Male subjects must commit to not donate sperm for a minimum of 90 days after the PET scan

Exclusion Criteria:

• Any known allergic reactions or hypersensitivity towards any compound of the study drug
• 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

Related Conditions & MeSH terms

• AL Amyloidosis
• Amyloidosis
• ATTR Amyloidosis
• Cardiac Amyloidosis
• Immunoglobulin Light-chain Amyloidosis

Intervention

Drug:
• [18F]florbetaben
All enrolled patients will undergo [18F]florbetaben PET imaging.

Locations

Country	Name	City	State
Germany	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
Spain	Hospital University Bellvitge	Barcelona
Spain	Hospital University Puerta de Hierro	Madrid
Spain	Clínica Universidad de Navarra	Pamplona
Spain	University of Salamanca	Salamanca
United Kingdom	Royal Free Hospital	London
United States	St Luke's Hospital	Kansas City	Kansas
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	University of Pittsburgh	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Life Molecular Imaging GmbH	pharmtrace klinische Entwicklung GmbH

Countries where clinical trial is conducted

United States,  Germany,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Sensitivity and specificity of [18F]florbetaben PET images for a differential diagnosis between AL CA, ATTR CA and non CA will be assessed.	In this exploratory endpoint the sensitivity and specificity of [18F]florbetaben PET images for a differential diagnosis between AL CA, ATTR CA and non CA will be assessed.	Up to 12 weeks
Primary	Sensitivity and specificity of the visual assessment of [18F]florbetaben PET images for the diagnosis of cardiac AL amyloidosis.	The results from the visual assessment of [18F]florbetaben PET images are compared to the clinical diagnosis established through histological verification of the presence or absence of AL amyloidosis with cardiac involvement determined either through endomyocardial biopsy or through extracardiac biopsy in conjunction with typical CMR or echocardiography imaging features as the standard of truth.	Up to 12 weeks
Secondary	Sensitivity and specificity of [18F]florbetaben PET for the diagnosis of cardiac AL amyloidosis using quantification.	The sensitivity and specificity of [18F]florbetaben PET for the diagnosis of cardiac AL amyloidosis will be determined by using quantitative image analysis.	Up to 12 weeks
Secondary	Correlation of quantitative [18F]florbetaben PET results with left ventricular ejection fraction (LV EF) and left ventricular mass (LV mass).	Correlation of quantitative [18F]florbetaben PET results with left ventricular ejection fraction (LV EF) and left ventricular mass (LV mass).	Up to 12 weeks
Secondary	Correlation of quantitative [18F]florbetaben PET results with AL CA stage I - IV based on FLC-diff, cTnT and NT-proBNP levels.	Correlation of quantitative [18F]florbetaben PET results with AL CA stage I - IV based on FLC-diff, cTnT and NT-proBNP levels.	Up to 12 weeks
Secondary	Impact of PET imaging (AL-CA/non AL-CA) on diagnostic thinking and patient management will be assessed with physician's questionnaires before and after the diagnostic work-up, and after receipt of the PET results.	The impact of PET imaging (AL-CA/non AL-CA) on diagnostic thinking and patient management will be assessed with physician's questionnaires before and after the diagnostic work-up, and after receipt of the PET results.	Up to 14 weeks
Secondary	Number of adverse events	Safety will be evaluated by collection of Adverse Events.	Up to 17 days after imaging visit