PET MRI Study in Patients With Cardiac Sarcoidosis

NCT03356756 | Completed

• 1 other identifier: 15-9933
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Myocarditis or inflammatory cardiomyopathy refers to inflammation of the heart muscle (the myocardium). Sarcoidosis is a multisystem granulomatous disorder that may involve the heart, causing inflammation, and potentially resulting in complications including arrhythmia and sudden death. The objective of this study is to evaluate the diagnostic and prognostic significance of simultaneous combined 18F-FDG PET and cardiac MRI imaging in the evaluation of inflammatory cardiomyopathies including cardiac sarcoidosis. Combined PET/MRI imaging may allow for detection and quantification of active myocardial inflammation as well as chronic fibrosis and scarring. Results of this study may allow for earlier detection of cardiac inflammation when compared with methods in current clinical use, and may lead to better understanding of the disease processes contributing to adverse outcomes. Elucidation of imaging findings associated with future adverse event risk may impact patient management such as providing an indication for pacemaker or defibrillator implantation, or escalation of medical therapy.

Conditions

Inflammatory Cardiomyopathy; Sarcoidosis

Outcome Measures

Primary Outcomes (1)

• The incremental value of combined 18F-FDG PET and cardiac MRI imaging in the evaluation of patients with suspected cardiac sarcoidosis or cardiac inflammation

  Patients will undergo standard clinical evaluation using modified consensus guidelines for the diagnosis of sarcoidosis. Following enrolment, patients will also undergo parallel assessment for cardiac involvement by PET/MRI. Comparison of cardiac involvement identified by modified consensus criteria and PET/MRI will be performed.

  Completion of enrollment, an average of two years

Secondary Outcomes (2)

• The differences in circulating plasma biomarkers between cardiac with suspected cardiac sarcoidosis and healthy people

  Completion of enrollment, an average of two years

• The prognostic significance of PET-MRI imaging findings in patients with cardiac inflammation

  Through study completion, an average of three years

Study Arms (1)

PET MRI exam

simultaneous combined 18F-FDG PET and cardiac MRI imaging (PET MRI) performed immediately after the PET CT exam.

Diagnostic Test: simultaneous combined 18F-FDG PET and cardiac MRI imaging

Interventions

simultaneous combined 18F-FDG PET and cardiac MRI imaging DIAGNOSTIC_TEST

Patients will undergo a research study performed with an integrated whole-body PET/MRI imaging system designed for simultaneous PET and MRI acquisition, immediately after standard of care PET/CT exam.

PET MRI exam

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients 18 years or older with known or suspected cardiac sarcoidosis or other inflammatory cardiomyopathy who are referred for clinically indicated 18F-FDG PET/CT imaging at University Health Network.

You may qualify if:

• The primary criterion for enrolment will be patients ≥18 years of age with known or suspected sarcoidosis or other inflammatory cardiomyopathy who are referred for clinically indicated 18F-FDG PET/CT imaging

You may not qualify if:

• Standard cardiac MRI contraindications include arrhythmia, claustrophobia, history of allergic reaction or other contraindication to gadolinium-based contrast agent, impaired renal function with eGFR \< 60 ml/min/1.73m2, pregnancy, breast-feeding, or any other general contraindication to MRI (pacemaker, cerebral aneurysm clips, shrapnel, etc).

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

University Health Network

Toronto, Ontario, M5G 2C4, Canada

Location

Related Publications (2)

• Cheung E, Ahmad S, Aitken M, Chan R, Iwanochko RM, Balter M, Metser U, Veit-Haibach P, Billia F, Moayedi Y, Ross HJ, Hanneman K. Combined simultaneous FDG-PET/MRI with T1 and T2 mapping as an imaging biomarker for the diagnosis and prognosis of suspected cardiac sarcoidosis. Eur J Hybrid Imaging. 2021 Dec 16;5(1):24. doi: 10.1186/s41824-021-00119-w.

  PMID: 34913098 RESULT

• Marschner CA, Aloufi F, Aitken M, Cheung E, Thavendiranathan P, Iwanochko RM, Balter M, Moayedi Y, Duero Posada J, Hanneman K. Combined FDG PET/MRI versus Standard-of-Care Imaging in the Evaluation of Cardiac Sarcoidosis. Radiol Cardiothorac Imaging. 2023 Sep 28;5(5):e220292. doi: 10.1148/ryct.220292. eCollection 2023 Oct.

  PMID: 38076597 RESULT

MeSH Terms

Conditions

Sarcoidosis

Condition Hierarchy (Ancestors)

Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Hypersensitivity, Delayed; Hypersensitivity; Immune System Diseases

Study Officials

• Kate Hanneman, MD

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2017
• First Posted: November 29, 2017
• Study Start: June 27, 2016
• Primary Completion: February 23, 2024
• Study Completion: February 23, 2024
• Last Updated: May 28, 2024

Record last verified: 2024-05

Locations

CA (1)