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

March 15, 2023 updated by: Andrei Iagaru, Stanford University
The investigators will evaluate the detection of cardiac sarcoidosis or inflammation using 18F-FSPG PET/MRI (or PET/CT for participants with metal implants).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

45

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • Stanford, California, United States, 94305
        • Stanford University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 18F-FSPG
Patients receive 18F-FSPG for detection of Cardiac Sarcoidosis or Inflammation
Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With 18F-FSPG Uptake on PET/MRI or PET/CT Fused Images Indicating Cardiac Involvement of Sarcoidosis
Time Frame: 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
average approximately 2 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Evidence of Whole Body 18F-FSPG Uptake on PET/MRI or PET/CT Fused Images Indicating Extra-cardiac Sarcoidosis
Time Frame: 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.
average approximately 2 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stanford University

Collaborators

GE Healthcare

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 2, 2017

Primary Completion (Actual)

September 28, 2021

Study Completion (Actual)

September 28, 2021

Study Registration Dates

First Submitted

March 10, 2017

First Submitted That Met QC Criteria

March 31, 2017

First Posted (Actual)

April 6, 2017

Study Record Updates

Last Update Posted (Actual)

April 7, 2023

Last Update Submitted That Met QC Criteria

March 15, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB-40376

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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