PET/MRI Evaluation of Cardiac Amyloid

Cardiac Amyloidosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03119558
• Other study ID #: IRB-35049
• Status: Completed
• Phase: Early Phase 1
• Start date: May 26, 2016
• Est. completion date: August 28, 2018

Study information

• Verified date: July 2019
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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:

1. Diagnosis of cardiac amyloidosis

2. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: August 28, 2018
• Est. primary completion date: August 23, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Amyloidosis
• Cardiac Amyloidosis

Intervention

Drug:
• 18F-Florbetaben (Neuraceq®) PET/MRI
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.

Locations

Country	Name	City	State
United States	Stanford University	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with 18F-Florbetaben (Neuraceq®) uptake on Fused PET/MRI Images	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	an estimated average of 2 hours