PET/MRI Evaluation of Cardiac Amyloid

18F-Florbetaben (Neuraceq®) 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.

Study Overview

• Status: Completed
• Conditions: Cardiac Amyloidosis
• Intervention / Treatment: Drug: 18F-Florbetaben (Neuraceq®) PET/MRI

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 9
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Stanford, California, United States, 94305
      • Stanford University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 18F-Florbetaben (Neuraceq®) PET/MRI; Participants with known or suspected cardiac amyloidosis will be injected with 8 mCi of 18F-Florbetaben (Neuraceq®) and undergo the PET/MRI image acquisition 45-60 minute post-injection. PET and MRI data will be acquired simultaneously to ensure optimal timing and spatial correspondence between MRI and PET data. Total scan time will take approximately 60 minutes.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Stanford University

Publications and helpful links

General Publications

• Baratto L, Park SY, Hatami N, Gulaka P, Vasanawala S, Yohannan TK, Herfkens R, Witteles R, Iagaru A. 18F-florbetaben whole-body PET/MRI for evaluation of systemic amyloid deposition. EJNMMI Res. 2018 Jul 24;8(1):66. doi: 10.1186/s13550-018-0425-1.

Study record dates

Study Major Dates

• Study Start (Actual): May 26, 2016
• Primary Completion (Actual): August 23, 2018
• Study Completion (Actual): August 28, 2018

Study Registration Dates

• First Submitted: April 13, 2017
• First Submitted That Met QC Criteria: April 13, 2017
• First Posted (Actual): April 18, 2017

Study Record Updates

• Last Update Posted (Actual): July 17, 2019
• Last Update Submitted That Met QC Criteria: July 16, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Proteostasis Deficiencies; Amyloidosis
• Other Study ID Numbers: IRB-35049

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No