Acute MyocarditisNCT04206163
Somatostatin Receptor Imaging in Acute Myocarditis and Cardiac Sarcoidosis
A study testing 68Ga-DOTA-TOC PET/CT and Blood sample in people with Acute Myocarditis and Cardiac Sarcoidosis, run by Vastra Gotaland Region at 1 site in Sweden.
Trial summary
This prospective imaging study investigates the diagnostic ability of Gallium-68 DOTA-TOC (68Ga-DOTA-TOC) positron emission tomography/computed tomography (PET/CT) in the clinical work-up of patients with 1) clinically suspected acute myocarditis (n=30-40) and 2) clinically suspected cardiac sarcoidosis (n=30-40)… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Acute Myocarditis, Cardiac Sarcoidosis
- What is being tested?
- 68Ga-DOTA-TOC PET/CT and Blood sample
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteSweden
- Study dates
- 20 Jan 2020to 24 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Willingness to participate in the study
- Provision of written informed consent
- All patients between the age of 18 and 85 of both genders
- Newly clinically suspected acute myocarditis or newly clinically suspected cardiac sarcoidosis with or without known extra-cardiac sarcoid
Who cannot join
- Pregnancy or lactation
- Severe obesity (limited by the scanner)
- Other known significant cardiac disease, including previous myocarditis
- Known tumour disease, especially (neuro)endocrine tumours
- Terminal disease(s), advanced psychiatric disease and/or significant dementia
- Recent or current immunosuppressive treatment
Show all 9Show fewer
- Recent or current somatostatin analogue (octreotide) therapy
- Known relative/absolute contraindications for contrast-enhanced MRI and/or PET/CT imaging
- Known contraindications for endomyocardial biopsy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Somatostatin Receptor Imaging in Inflammatory Heart Disease
This prospective imaging study investigates the diagnostic ability of Gallium-68 DOTA-TOC (68Ga-DOTA-TOC) positron emission tomography/computed tomography (PET/CT) in the clinical work-up of patients with 1) clinically suspected acute myocarditis (n=30-40) and 2) clinically suspected cardiac sarcoidosis (n=30-40) using clinical diagnostic criteria as well as endomyocardial biopsy as reference. Furthermore, 68Ga-DOTA-TOC PET/CT findings will be compared with results from contrast-enhanced magnetic resonance imaging (MRI) and in case of cardiac sarcoidosis even Fluorine-18 fluorodeoxyglucose (18F-FDG) PET/CT, which are both performed as part of the clinical routine work-up.
- Conditions
- Acute Myocarditis, Cardiac Sarcoidosis
- Being tested
- 68Ga-DOTA-TOC PET/CT, Blood sample
- Keywords
- Myocarditis, Cardiac sarcoidosis, Inflammatory cardiomyopathy, Cardiomyopathy, Heart disease, Cardiovascular disease, Somatostatin, 68Ga-DOTA-TOC, Positron emission tomography
- Medical subject headings
- Myocarditis, Cardiomyopathies, Heart Diseases, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
68Ga-DOTA-TOC PET/CTDiagnostic test
Somatostatin receptor imaging
Blood sampleBiological
Analysis of inflammatory biomarkers
| Study group | Role | What they receive |
|---|---|---|
| Acute myocarditis | Experimental | Included patients with clinically suspected acute myocarditis (n=30-40) will undergo a 68Ga-DOTA-TOC PET/CT and a blood sample will be taken. Furthermore, participants will undergo a contrast-enhanced MRI and endomyocardial biopsy (if clinically indicated) as part of the clinical routine work-up. Receives: Diagnostic Test: 68Ga-DOTA-TOC PET/CT; Biological: Blood sample |
| Cardiac sarcoidosis | Experimental | Included patients with clinically suspected cardiac sarcoidosis (n=30-40) will undergo a 68Ga-DOTA-TOC PET/CT and a blood sample will be taken. Furthermore, participants will undergo a contrast-enhanced MRI, 18F-FDG PET/CT and endomyocardial biopsy as part of the clinical routine work-up. Receives: Diagnostic Test: 68Ga-DOTA-TOC PET/CT; Biological: Blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity of 68Ga-DOTA-TOC PET/CT versus contrast-enhanced MRI in patients with clinically suspected acute myocarditis (using clinical diagnostic criteria as well as endomyocardial biopsy as reference)
Measured: Completion of enrollment, approximately 2 years
Specificity of 68Ga-DOTA-TOC PET/CT versus contrast-enhanced MRI in patients with clinically suspected acute myocarditis (using clinical diagnostic criteria as well as endomyocardial biopsy as reference)
Measured: Completion of enrollment, approximately 2 years
Sensitivity of 68Ga-DOTA-TOC PET/CT versus contrast-enhanced MRI and 18F-FDG PET/CT in patients with clinically suspected cardiac sarcoidosis (using clinical diagnostic criteria as well as endomyocardial biopsy as reference)
Measured: Completion of enrollment, approximately 5 years
Specificity of 68Ga-DOTA-TOC PET/CT versus contrast-enhanced MRI and 18F-FDG PET/CT in patients with clinically suspected cardiac sarcoidosis (using clinical diagnostic criteria as well as endomyocardial biopsy as reference)
Measured: Completion of enrollment, approximately 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2019
- Study start20 Jan 2020
- Primary completion24 Jun 2024
- Study completion24 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute MyocarditisStudies of the same condition, open and under way.
- More trials run by Vastra Gotaland RegionThe 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vastra Gotaland Region
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Christian L Polte, MD, PhD, MSc, Principal investigator, Sahlgrenska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04206163
- Sponsor's protocol ID
- 2019-001300-38
- Other IDs
- 2019
- Status last verified
- Sep 2024
- First submitted
- 13 Dec 2019
- Last updated
- 27 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Somatostatin Receptor Imaging in Inflammatory Heart Disease
- ClinicalTrials.gov ID
- NCT04206163
- Acronym / sponsor ID
- 2019-001300-38
- Conditions
- Acute Myocarditis, Cardiac Sarcoidosis
- Keywords
- Myocarditis, Cardiac sarcoidosis, Inflammatory cardiomyopathy, Cardiomyopathy, Heart disease, Cardiovascular disease, Somatostatin, 68Ga-DOTA-TOC
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Vastra Gotaland RegionOther government
- Study start
- 20 Jan 2020 (actual)
- Primary completion
- 24 Jun 2024 (actual)
- Study completion
- 24 Jun 2024 (actual)
- First posted
- 20 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This prospective imaging study investigates the diagnostic ability of Gallium-68 DOTA-TOC (68Ga-DOTA-TOC) positron emission tomography/computed tomography (PET/CT) in the clinical work-up of patients with 1) clinically suspected acute myocarditis (n=30-40) and 2) clinically suspected cardiac sarcoidosis (n=30-40) using clinical diagnostic criteria as well as endomyocardial biopsy as reference. Furthermore, 68Ga-DOTA-TOC PET/CT findings will be compared with results from contrast-enhanced magnetic resonance imaging (MRI) and in case of cardiac sarcoidosis even Fluorine-18 fluorodeoxyglucose (18F-FDG) PET/CT, which are both performed as part of the clinical routine work-up.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acute myocarditis | Experimental | Diagnostic Test: 68Ga-DOTA-TOC PET/CT, Biological: Blood sampleIncluded patients with clinically suspected acute myocarditis (n=30-40) will undergo a 68Ga-DOTA-TOC PET/CT and a blood sample will be taken. Furthermore, participants will undergo a contrast-enhanced MRI and endomyocardial biopsy (if clinically indicated) as part of the clinical routine work-up. |
| Cardiac sarcoidosis | Experimental | Diagnostic Test: 68Ga-DOTA-TOC PET/CT, Biological: Blood sampleIncluded patients with clinically suspected cardiac sarcoidosis (n=30-40) will undergo a 68Ga-DOTA-TOC PET/CT and a blood sample will be taken. Furthermore, participants will undergo a contrast-enhanced MRI, 18F-FDG PET/CT and endomyocardial biopsy as part of the clinical routine work-up. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Willingness to participate in the study
- Provision of written informed consent
- All patients between the age of 18 and 85 of both genders
- Newly clinically suspected acute myocarditis or newly clinically suspected cardiac sarcoidosis with or without known extra-cardiac sarcoid
Key exclusion criteria (9 listed)
- Pregnancy or lactation
- Severe obesity (limited by the scanner)
- Other known significant cardiac disease, including previous myocarditis
- Known tumour disease, especially (neuro)endocrine tumours
- Terminal disease(s), advanced psychiatric disease and/or significant dementia
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 |
|---|---|---|
| 68Ga-DOTA-TOC PET/CTSomatostatin receptor imaging | Diagnostic test | Acute myocarditis, Cardiac sarcoidosis |
| Blood sampleAnalysis of inflammatory biomarkers | Biological | Acute myocarditis, Cardiac sarcoidosis |
Primary outcome
Sensitivity of 68Ga-DOTA-TOC PET/CT versus contrast-enhanced MRI in patients with clinically suspected acute myocarditis (using clinical diagnostic criteria as well as endomyocardial biopsy as reference)
Time frame: Completion of enrollment, approximately 2 years
Specificity of 68Ga-DOTA-TOC PET/CT versus contrast-enhanced MRI in patients with clinically suspected acute myocarditis (using clinical diagnostic criteria as well as endomyocardial biopsy as reference)
Time frame: Completion of enrollment, approximately 2 years
Sensitivity of 68Ga-DOTA-TOC PET/CT versus contrast-enhanced MRI and 18F-FDG PET/CT in patients with clinically suspected cardiac sarcoidosis (using clinical diagnostic criteria as well as endomyocardial biopsy as reference)
Time frame: Completion of enrollment, approximately 5 years
Specificity of 68Ga-DOTA-TOC PET/CT versus contrast-enhanced MRI and 18F-FDG PET/CT in patients with clinically suspected cardiac sarcoidosis (using clinical diagnostic criteria as well as endomyocardial biopsy as reference)
Time frame: Completion of enrollment, approximately 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2024.
- Individual participant dataSharing planned: No
Related trials for Acute Myocarditis
Recruiting
Heart@Home Safety and Efficacy of Hospital-at-Home Care Versus Standard Hospitalization in Cardiac Patients
Myocardial Infarction, Myocarditis Acute
RecruitingObservational study
MYocarditis and/or Pericarditis Following mRNA COVID-19 VACCination National Surveillance Study
Myocarditis, Myocarditis Acute
Recruiting
Routine Versus Provisional Distal Perfusion Catheter Placement in Patients Undergoing Mechanical Circulatory Support
Cardiogenic Shock, Acute Myocardial Infarction of Inferior Wall
Not yet recruitingPhase 1
64Cu-GRIP B in Patients With Acute Myocarditis
Acute Myocarditis
Enrolling by invitationObservational study
Multimodal Physiologic State Intelligence Study
Heart Failure, Cardiomyopathies
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.
Christian L Polte, MD, PhD, MSc principal investigator
Sahlgrenska University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 68Ga-DOTA-TOC PET/CT and Blood sample in people with Acute Myocarditis and Cardiac Sarcoidosis, run by Vastra Gotaland Region at 1 site in Sweden.
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 9 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: finished, as of the sponsor's last update on 27 Sep 2024. 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 Sweden. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Sensitivity of 68Ga-DOTA-TOC PET/CT versus contrast-enhanced MRI in patients with clinically suspected acute myocarditis (using clinical diagnostic criteria as well as endomyocardial biopsy as reference) (time frame: Completion of enrollment, approximately 2 years). The study lists 4 primary outcomes in all. 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 27 Sep 2024.