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

Phase 2

Terminated

• Conditions: Myocardial Inflammation; Cardiac Sarcoidosis
• Interventions: Drug: 18F-FSPG

• Registration Number: NCT03103490
• Lead Sponsor: Stanford University

Brief Summary

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

Detailed 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.

Study Timeline

• Study First Submitted: 2017-03-10
• Study First Submitted QC: 2017-03-31
• Study First Posted: 2017-04-06
• Study Start: 2017-08-02
• Primary Completion: 2021-09-28
• Study Completion: 2021-09-28
• Status Verified: 2023-03
• Results First Submitted: 2023-03-15
• Results First Submitted QC: 2023-03-15
• Last Update Submitted: 2023-03-15
• Results First Posted: 2023-04-07
• Last Update Posted: 2023-04-07

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 45

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Number of Participants With 18F-FSPG Uptake on PET/MRI or PET/CT Fused Images Indicating Cardiac Involvement of Sarcoidosis	average approximately 2 hours	Diffuse (widespread), focal (point) and focal-on-diffuse (combination of the two) patterns of 18F-FSPG uptake will be considered to be positive findings indicating cardiac involvement of sarcoidosis or inflammation

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Evidence of Whole Body 18F-FSPG Uptake on PET/MRI or PET/CT Fused Images Indicating Extra-cardiac Sarcoidosis	average approximately 2 hours	The whole-body PET/MRI images will be evaluated for findings of extra-cardiac sarcoidosis. Evidence of 18F-FSPG uptake within the whole body will indicate a positive finding for the presence of extra-cardiac sarcoidosis.

Trial Locations

Locations (1)

Stanford University; 🇺🇸 Stanford, California, United States