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PET/MRI Evaluation of Cardiac Amyloid

Primary Purpose

Cardiac Amyloidosis

Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
18F-Florbetaben (Neuraceq®) PET/MRI
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Cardiac Amyloidosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Stanford University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

18F-Florbetaben (Neuraceq®) PET/MRI

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
April 13, 2017
Last Updated
July 16, 2019
Sponsor
Stanford University
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1. Study Identification

Unique Protocol Identification Number
NCT03119558
Brief Title
PET/MRI Evaluation of Cardiac Amyloid
Official Title
18F-Florbetaben (Neuraceq®) PET/MRI Evaluation of Cardiac Amyloid
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
May 26, 2016 (Actual)
Primary Completion Date
August 23, 2018 (Actual)
Study Completion Date
August 28, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University

4. Oversight

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
Data Monitoring Committee
No

5. 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.
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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Amyloidosis

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
18F-Florbetaben (Neuraceq®) PET/MRI
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
18F-Florbetaben (Neuraceq®) PET/MRI
Intervention Description
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 Outcome Measure Information:
Title
Number of participants with 18F-Florbetaben (Neuraceq®) uptake on Fused PET/MRI Images
Description
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
Time Frame
an estimated average of 2 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrei Iagaru, MD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30043115
Citation
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.
Results Reference
derived

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PET/MRI Evaluation of Cardiac Amyloid

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