PET/MRI Evaluation of Cardiac Amyloid

• ClinicalTrials.gov Identifier: NCT03119558
• Recruitment Status: Completed
• First Posted: April 18, 2017
• Last Update Posted: July 17, 2019
• Sponsor: Stanford University
• Information provided by (Responsible Party): Andrei Iagaru, Stanford University

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Cardiac Amyloidosis	Drug: 18F-Florbetaben (Neuraceq®) PET/MRI	Early Phase 1

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 9 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: 18F-Florbetaben (Neuraceq®) PET/MRI Evaluation of Cardiac Amyloid
• Actual Study Start Date: May 26, 2016
• Actual Primary Completion Date: August 23, 2018
• Actual Study Completion Date: August 28, 2018

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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)

Contacts and Locations

Locations

United States, California

Stanford University

Stanford, California, United States, 94305

Sponsors and Collaborators

Stanford University

Investigators

• Principal Investigator: Andrei Iagaru, MD; Stanford University

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Baratto L, Park SY, Hatami N, Gulaka P, Vasanawala S, Yohannan TK, Herfkens R, Witteles R, Iagaru A. (18)F-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.

• Responsible Party: Andrei Iagaru, Associate Professor of Radiology - Nuclear Medicine, Stanford University
• ClinicalTrials.gov Identifier: NCT03119558
• Other Study ID Numbers: IRB-35049
• First Posted: April 18, 2017
• Last Update Posted: July 17, 2019
• Last Verified: July 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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

Additional relevant MeSH terms:

Amyloidosis; Proteostasis Deficiencies; Metabolic Diseases