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Completed

NCT Number: NCT03119558

PET/MRI Evaluation of Cardiac Amyloid

Cardiac amyloidosis is a disorder characterized by the deposition of abnormal proteins called amyloid in the heart tissue. This makes it difficult for the heart to function properly. The investigators wish to evaluate if the radiopharmaceutical 18F-Florbetaben (Neuraceq®) that targets beta amyloid can also identify cardiac amyloid deposition.

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Key information

Conditions

Cardiac Amyloidosis Amyloid Neuropathies Amyloid Neuropathies, Familial Amyloidosis Amyloidosis, Familial Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Heredodegenerative Disorders, Nervous System Metabolic Diseases Metabolism, Inborn Errors Nervous System Diseases Neurodegenerative Diseases Neuromuscular Diseases Nutritional and Metabolic Diseases Peripheral Nervous System Diseases Proteostasis Deficiencies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Stanford University

Stanford, California, 94305, United States

About this study

The use of hybrid positron emission tomography/ magnetic resonance imaging (PET/MRI) scanners in clinical practice enhance the ability to evaluate the heart from both an anatomical and functional perspective. It is hypothesized that an increased PET signal of 18F-Florbetaben (Neuraceq®) will be detected in cardiac amyloid deposits within the heart tissue, while the MRI provides the anatomical information. The ability to reliably and non-invasively image amyloid deposition in the heart would be potentially advantageous in the following scenarios:

  • Diagnosis of cardiac amyloidosis
  • Decreasing unnecessary invasive myocardial procedures.

The investigators believe this trial will help expand the use of current PET amyloid tracers and help many patients who currently undergo myocardial biopsy for the diagnosis of cardiac amyloid.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient is ≥ 18 years old at the time of the scan
  • Patient with known or suspected cardiac amyloidosis.
  • Patient is capable of complying with study procedures

Exclusion criteria

  • Patient is pregnant or nursing
  • Metallic implants (contraindicated for MRI)
  • History of renal insufficiency (only for MRI contrast administration)

Treatment and study plan

18F-Florbetaben (Neuraceq®) PET/MRI

Drug

Administration of 8.0 mCi 18F-Florbetaben (Neuraceq®) IV followed by simultaneous acquisition PET emission and cardiac MRI sequence scan 45-60 minutes post-injection.

Primary outcomes

  1. Number of participants with 18F-Florbetaben (Neuraceq®) uptake on Fused PET/MRI Images

    Time frame: an estimated average of 2 hours

    Diffuse (widespread), focal (point) and focal-on-diffuse (combination of the two) patterns of 18F-Florbetaben uptake will be considered positive findings indicating cardiac amyloidosis

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Official study title

18F-Florbetaben (Neuraceq®) PET/MRI Evaluation of Cardiac Amyloid

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Apr 18, 2017
Registry last updated
Jul 17, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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