18F-FSPG PET/MRI or PET/CT Imaging of Cardiac Sarcoidosis or Inflammation

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-02

Study Completion Date

2021-09-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The investigators will evaluate the detection of cardiac sarcoidosis or inflammation using 18F-FSPG PET/MRI (or PET/CT for participants with metal implants).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Feasibility and Accuracy of Hybrid Magnetic Resonance and Positron Emission Tomography With 18F-Fluorodeoxyglucose in Diagnosing Cardiac Sarcoidosis

NCT03923049

Cardiac Sarcoidosis

TERMINATED NA

Diagnostic Potential of PET/MRI in Cardiac Sarcoidosis

NCT03561025

Sarcoidosis Cardiomyopathies

COMPLETED NA

PET MRI Study in Patients With Cardiac Sarcoidosis

NCT03356756

Inflammatory Cardiomyopathy Sarcoidosis

COMPLETED

Non-Invasive Characterization in Cardiac Sarcoidosis

NCT02017522

Cardiac Sarcoidosis

TERMINATED NA

d68Ga-DOTATATE PET/CT Assessment of Cardiac Sarcoidosis

NCT03549598

Cardiac Sarcoidosis

COMPLETED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

PET/MRI scans will be performed with a whole-body PET/MR imaging system capable of simultaneous PET and MR imaging (SIGNA, GE Healthcare, Milwaukee, WI). Approximately 45-60 minutes after IV injection of 8 mCi of 18F-FSPG, PET emission scanning and MRI acquisition T1 weighted scanning will begin imaging both whole body and the heart.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cardiac Sarcoidosis Myocardial Inflammation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

18F-FSPG

Patients receive 18F-FSPG for detection of Cardiac Sarcoidosis or Inflammation

Group Type OTHER

18F-FSPG

Intervention Type DRUG

Patients receive 8mCi of 18F-FSPG and undergo PET/MRI imaging (or PET/CT for patients with metal implants) to determine the ability of 18F-FSPG to localize to cardiac sarcoidosis or myocardial inflammation.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

18F-FSPG

Patients receive 8mCi of 18F-FSPG and undergo PET/MRI imaging (or PET/CT for patients with metal implants) to determine the ability of 18F-FSPG to localize to cardiac sarcoidosis or myocardial inflammation.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patient is ≥ 18 years old at the time of the scan
* Patient with known or suspected cardiac sarcoidosis.
* Patient is capable of complying with study procedures
* Patient can remain still for duration of imaging procedure

Exclusion Criteria

* Patient is pregnant or nursing
* Metallic implants (contraindicated for MRI)
* History of renal insufficiency (only for MRI contrast administration)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No