Nutritional and Metabolic Diseases

All Conditions

Neoplasms

Immune System Diseases

Blood and Lymph Conditions

Rare Diseases

Amyloidosis

Immunoglobulin Light-chain Amyloidosis

Proteostasis Deficiencies

Metabolic Diseases

Neoplasms, Plasma Cell

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Immunoproliferative Disorders

Paraproteinemias

AL Amyloidosis

Patients will undergo on the same day:

* 18F-florbetaben PET-CT scans. The dose to be injected intravenously (6 second/mL) will be 370 MBq (for a 70 Kg patient);
* standard assessment of clonal and organ disease;
* echocardiography;
* cardiac magnetic resonance.

All the patients will undergo those evaluations at baseline and 6 months after treatment initiation.

[18F]Florbetaben

Giovanni Palladini, MD, PhD

Anna Carnevale Baraglia

Giovanni Palladini

This will be a systematic, combined, prospective assessment of the novel echographic, CMR, and PET imaging tools in newly-diagnosed patients with cardiac AL amyloidosis at baseline and after treatment.

Novel Imaging Tools in Newly-diagnosed Patients With Cardiac AL Amyloidosis

Molecular, Magnetic Resonance, and Echocardiographic Imaging Combined With Biomarkers of Cardiac and Clonal Disease to Predict Survival and Assess Response to Therapy in Cardiac AL Amyloidosis

- for CMR: T1, T2, ECV, indexed volumes, mass, ejection fraction (EF);

- for echocardiography: left ventricular wall thickness (mLVW), EF, 2D-GLS, midwall fractional shortening (mFS), and stroke volume index (SVI);

The same variables considered at baseline will be measured 6 months after initiation of chemotherapy targeting the amyloid plasma cell clone. Changes in these variables compared to baseline will be considered.

IRCCS Policlinico S. Matteo

Principal Investigator

Heart and Blood Diseases

Multiple Myeloma

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Blood Protein Disorders

Hematologic Diseases

Hemorrhagic Disorders

* Maximally 18 subjects with multiple myeloma (up to 6 subjects in whom amyloidosis in suspected and up to 12 subjects in whom amyloidosis is not suspected)
* Intravenous injection of \[18F\]Florbetaben and PET/CT scanning
* Intervention: Drug (\[18F\]Florbetaben)

* Drug: \[18F\]Florbetaben
* \[18F\]Florbetaben PET/CT Imaging for detecting amyloidosis in multiple myeloma
* Other name: Neuraceq
* Amount: 300 MBq ± 20% bolus, 10mL intravenously

Jae-Cheol Jo, PhD

\[18F\]Florbetaben PET/CT imaging will noninvasively assess amyloid deposition in systemic amyloidosis.

Diagnostic validity of \[18F\]Florbetaben PET for detecting amyloidosis will be assessed in subjects with multiple myeloma.

Detection of Amyloidosis in Multiple Myeloma Patients by [18F]Florbetaben Positron Emission Tomography

A Pilot Phase 2, Open-label, Non-randomized, Single Center Study to Explore Diagnostic Validity of [18F]Florbetaben Positron Emission Tomography for Detecting Amyloidosis in Multiple Myeloma Patients

Sensitivity and specificity of \[18F\]Florbetaben PET/CT for the diagnosis of subjects with clinical, laboratory, radiological, or histopathological evidence of amyloidosis

Sensitivity and specificity of \[18F\]Florbetaben PET/CT for the diagnosis of affected organs with clinical, laboratory, radiological, or histopathological evidence of amyloidosis

Correlation of \[18F\]Florbetaben activity with clinical/radiological/histopathological indices of amyloidosis severity

Ulsan University Hospital

Assistant professor

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.

All enrolled patients will undergo \[18F\]florbetaben PET imaging.

[18F]florbetaben

Iris Hardewig, PhD

Aleksandar Jovalekic, PhD

Andrew Stephens, MD, PhD

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.

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.

All eligible patients will receive a single administration of the imaging agent \[18F\]florbetaben at a radioactive dose of 300 MBq.

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

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

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.

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.

The sensitivity and specificity of \[18F\]florbetaben PET for the diagnosis of cardiac AL amyloidosis will be determined by using quantitative image analysis.

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 AL CA stage I - IV based on FLC-diff, cTnT and NT-proBNP levels.

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.

Safety will be evaluated by collection of Adverse Events.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Novel Imaging Tools in Newly-diagnosed Patients With Cardiac AL Amyloidosis	NCT04392960	AL Amyloidosis	[18F]Florbetabe...	18 Years -	IRCCS Policlinico S. Matteo
Detection of Amyloidosis in Multiple Myeloma Patients by [18F]Florbetaben Positron Emission Tomography	NCT03779815	Multiple Myelom...	[18F]Florbetabe...	19 Years -	Ulsan University Hospital
Efficacy of [18F]Florbetaben PET for Diagnosis of Cardiac AL Amyloidosis	NCT05184088	Cardiac Amyloid... AL Amyloidosis ATTR Amyloidosi...	[18F]florbetabe...	18 Years -	Life Molecular Imaging SA

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