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

NCT03103490 | Terminated Phase 2 Results DMC FDA Drug

• 1 other identifier: IRB-40376
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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).

Conditions

Cardiac Sarcoidosis; Myocardial Inflammation

Keywords

PET/MR

Outcome Measures

Primary Outcomes (1)

• 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

  average approximately 2 hours

Secondary Outcomes (1)

• 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

Study Arms (1)

18F-FSPG

OTHER

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

Drug: 18F-FSPG

Interventions

18F-FSPG 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.

18F-FSPG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Stanford University: lead
• GE Healthcare: collaborator

Study Sites (1)

Stanford University

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Myocarditis

Interventions

4-(3-fluoropropyl)glutamic acid

Condition Hierarchy (Ancestors)

Cardiomyopathies; Heart Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Andrei Iagaru
• Organization: Professor of Radiology (Nuclear Medicine)

aiagaru@stanford.edu

(650) 725-4711

Study Officials

• Andrei Iagaru, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Radiology

Study Record Dates

• First Submitted: March 10, 2017
• First Posted: April 6, 2017
• Study Start: August 2, 2017
• Primary Completion: September 28, 2021
• Study Completion: September 28, 2021
• Last Updated: April 7, 2023
• Results First Posted: April 7, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)