Cardiac SarcoidosisPhase 2NCT03103490
18F-FSPG PET/MRI or PET/CT Imaging of Cardiac Sarcoidosis or Inflammation
A Phase 2 study testing 18F-FSPG in people with Cardiac Sarcoidosis and Myocardial Inflammation, run by Stanford University at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Sarcoidosis, Myocardial Inflammation
- What is being tested?
- 18F-FSPG
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Aug 2017to 28 Sep 2021
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patient is pregnant or nursing
- Metallic implants (contraindicated for MRI)
- History of renal insufficiency (only for MRI contrast administration)
Trial locations and contacts
1 site in 1 country.
About this study
The investigators will evaluate the detection of cardiac sarcoidosis or inflammation using 18F-FSPG PET/MRI (or PET/CT for participants with metal implants).
Read the 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.
- Conditions
- Cardiac Sarcoidosis, Myocardial Inflammation
- Being tested
- 18F-FSPG
- Keywords
- PET/MR
- Medical subject headings
- Myocarditis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F-FSPGDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 18F-FSPG | Other | Patients receive 18F-FSPG for detection of Cardiac Sarcoidosis or Inflammation Receives: Drug: 18F-FSPG |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
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.
Measured: average approximately 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2017
- Study start2 Aug 2017
- Primary completion28 Sep 2021
- Study completion28 Sep 2021
Why it stopped: Loss of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cardiac SarcoidosisStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- GE Healthcare
- Responsible party
- Principal investigator, Andrei Iagaru, Stanford University
- Investigators
- Andrei Iagaru, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03103490
- Sponsor's protocol ID
- IRB-40376
- Status last verified
- Mar 2023
- First submitted
- 10 Mar 2017
- Last updated
- 7 Apr 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 18F-FSPG PET/MRI or PET/CT Imaging of Cardiac Sarcoidosis or Inflammation
- ClinicalTrials.gov ID
- NCT03103490
- Acronym / sponsor ID
- IRB-40376
- Conditions
- Cardiac Sarcoidosis, Myocardial Inflammation
- Keywords
- PET/MR
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Loss of funding
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- GE Healthcare
- Study start
- 2 Aug 2017 (actual)
- Primary completion
- 28 Sep 2021 (actual)
- Study completion
- 28 Sep 2021 (actual)
- First posted
- 6 Apr 2017 (actual)
- Results
- Posted 7 Apr 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 18F-FSPG | Other | Drug: 18F-FSPGPatients receive 18F-FSPG for detection of Cardiac Sarcoidosis or Inflammation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Patient is pregnant or nursing
- Metallic implants (contraindicated for MRI)
- History of renal insufficiency (only for MRI contrast administration)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 18F-FSPGPatients 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. | Drug | 18F-FSPG |
Primary outcome
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
1 secondary outcome
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Cardiac Sarcoidosis
RecruitingPhase 2
Repurposing Tilmanocept for Cardiac Sarcoidosis
Cardiac Sarcoidosis
RecruitingObservational study
Cardiac Sarcoidosis Multi-Center Prospective Cohort
Cardiac Sarcoidosis
RecruitingObservational study
Prognostic Value of Clinical Cardiovascular MRI
Sarcoidosis
Recruiting
A Prospective Diagnostic Trial of Al[¹⁸F]F-NOTA-folate PET in Patients With Suspected Cardiac Sarcoidosis and Infective Endocarditis
Cardiac Sarcoidosis, Infective Endocarditis
RecruitingObservational study
Cardiomyopathies and Heart Muscle Diseases: Cardiac Imaging in the Evaluation of Myocardial Fibrosis Transition
Heart Failure With Preserved Ejection Fraction, Hypertrophic Cardiomyopathy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrei Iagaru, MD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 18F-FSPG in people with Cardiac Sarcoidosis and Myocardial Inflammation, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 7 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Apr 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2023.