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

Stanford University

Status and phase: Terminated; Phase 2

Conditions: Myocardial Inflammation; Cardiac Sarcoidosis

Treatments: Drug: 18F-FSPG

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03103490

IRB-40376

Details and patient eligibility

About

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

Full description

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.

Enrollment: 45 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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45 participants in 1 patient group

18F-FSPG

Other group

Description:

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

Treatment:

Drug: 18F-FSPG