Back to results18F-FSPG PET/MRI or PET/CT Imaging of Cardiac Sarcoidosis or Inflammation
Primary Purpose
Cardiac Sarcoidosis, Myocardial Inflammation
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
18F-FSPG
Sponsored by
About this trial
This is an interventional diagnostic trial for Cardiac Sarcoidosis focused on measuring PET/MR
Eligibility Criteria
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)
Sites / Locations
- Stanford University
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
18F-FSPG
Arm Description
Patients receive 18F-FSPG for detection of Cardiac Sarcoidosis or Inflammation
Outcomes
Primary Outcome Measures
Number of Participants With 18F-FSPG Uptake on PET/MRI or PET/CT Fused Images Indicating Cardiac Involvement of Sarcoidosis
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
Number of Participants With Evidence of Whole Body 18F-FSPG Uptake on PET/MRI or PET/CT Fused Images Indicating Extra-cardiac Sarcoidosis
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.
Full Information
NCT ID
NCT03103490
First Posted
March 10, 2017
Last Updated
March 15, 2023
Sponsor
Stanford University
Collaborators
GE Healthcare
1. Study Identification
Unique Protocol Identification Number
NCT03103490
Brief Title
18F-FSPG PET/MRI or PET/CT Imaging of Cardiac Sarcoidosis or Inflammation
Official Title
18F-FSPG PET/MRI or PET/CT Imaging of Cardiac Sarcoidosis or Inflammation
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Terminated
Why Stopped
Loss of funding
Study Start Date
August 2, 2017 (Actual)
Primary Completion Date
September 28, 2021 (Actual)
Study Completion Date
September 28, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
Collaborators
GE Healthcare
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Sarcoidosis, Myocardial Inflammation
Keywords
PET/MR
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
45 (Actual)
8. Arms, Groups, and Interventions
Arm Title
18F-FSPG
Arm Type
Other
Arm Description
Patients receive 18F-FSPG for detection of Cardiac Sarcoidosis or Inflammation
Intervention Type
Drug
Intervention Name(s)
18F-FSPG
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of Participants With 18F-FSPG Uptake on PET/MRI or PET/CT Fused Images Indicating Cardiac Involvement of Sarcoidosis
Description
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
Time Frame
average approximately 2 hours
Secondary Outcome Measure Information:
Title
Number of Participants With Evidence of Whole Body 18F-FSPG Uptake on PET/MRI or PET/CT Fused Images Indicating Extra-cardiac Sarcoidosis
Description
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.
Time Frame
average approximately 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 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)
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
Learn more about this trial
18F-FSPG PET/MRI or PET/CT Imaging of Cardiac Sarcoidosis or Inflammation
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