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18F-FSPG for Myocarditis

Phase 2

Waitlist Available

Led By Andrei Iagaru, MD

Research Sponsored by Stanford University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up average approximately 2 hours

Awards & highlights

Study Summary

This trial will look at whether PET/MRI can detect inflammation of the heart caused by sarcoidosis.

Eligible Conditions

Cardiac Sarcoidosis
Myocarditis

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ average approximately 2 hours

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~average approximately 2 hours

This trial's timeline: 3 weeks for screening, Varies for treatment, and average approximately 2 hours for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of Participants With 18F-FSPG Uptake on PET/MRI or PET/CT Fused Images Indicating Cardiac Involvement of Sarcoidosis

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

Side effects data

From 2016 Phase 2 trial • 7 Patients • NCT02599194

14%

Elevated blood ammonia

100%

80%

60%

40%

20%

Study treatment Arm

18F-FSPG and 18F-FDG Intragroup Comparision

Trial Design

1Treatment groups

Experimental Treatment

Group I: 18F-FSPGExperimental Treatment1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

18F-FSPG

2015

Completed Phase 2

~10

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Stanford UniversityLead Sponsor

2,390 Previous Clinical Trials

17,340,682 Total Patients Enrolled

GE HealthcareIndustry Sponsor

290 Previous Clinical Trials

631,026 Total Patients Enrolled

1 Trials studying Myocarditis

52 Patients Enrolled for Myocarditis

Andrei Iagaru, MDPrincipal Investigator - Stanford University

Lucile Packard Children's Hospital Stanford, Stanford Hospital, Stanford Hospital and Clinics

University De Medical Si Farm (Medical School)

Stanford University Hospital (Residency)

6 Previous Clinical Trials

497 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has this sort of medical experiment ever been conducted before?

"This medication has been under investigation since 2017, when a GE Healthcare-funded study involving 50 participants concluded. Thanks to the results of this trial, it was approved for Phase 2 drug trials and there are currently 3 active studies conducted in multiple sites across one nation."

Answered by AI

How many volunteers are participating in the trial at its peak?

"Affirmative. Per clinicaltrials.gov, this trial is currently enrolling individuals. It first appeared on the 2nd of August 2017 and has been recently updated by March 31st 2022--seeking a total of 50 participants from 1 medical centre."

Answered by AI

Has this intervention obtained regulatory clearance from the FDA?

"Considering it is currently undergoing a Phase 2 trial, which has collected some data regarding safety but none concerning efficacy, our team gave the treatment an overall score of 2."

Answered by AI

Is enrollment for this research initiative still available to participants?

"Affirmative. Information hosted on clinicaltrials.gov specifies that this trial, which was first posted August 2nd 2017, is actively enrolling participants. The research requires 50 people to be recruited from a single medical centre."

Answered by AI

What precedent has been established with regard to this therapeutic approach?

"Currently, 3 clinical trials are underway to evaluate the efficacy of this treatment. None are in Phase 3 yet and the majority of them are based at Stanford University, California with an additional three located elsewhere."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Andrei Iagaru 2017. "18F-FSPG PET/MRI or PET/CT Imaging of Cardiac Sarcoidosis or Inflammation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03103490.