Back to resultsSomatostatin Receptor Imaging in Acute Myocarditis and Cardiac Sarcoidosis
Primary Purpose
Acute Myocarditis, Cardiac Sarcoidosis
Status
Recruiting
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
68Ga-DOTA-TOC PET/CT
Blood sample
Sponsored by
About this trial
This is an interventional diagnostic trial for Acute Myocarditis focused on measuring Myocarditis, Cardiac sarcoidosis, Inflammatory cardiomyopathy, Cardiomyopathy, Heart disease, Cardiovascular disease, Somatostatin, 68Ga-DOTA-TOC, Positron emission tomography
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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
Sites / Locations
- Sahlgrenska University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Acute myocarditis
Cardiac sarcoidosis
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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)
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)
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)
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)
Secondary Outcome Measures
Full Information
NCT ID
NCT04206163
First Posted
December 13, 2019
Last Updated
April 27, 2022
Sponsor
Vastra Gotaland Region
1. Study Identification
Unique Protocol Identification Number
NCT04206163
Brief Title
Somatostatin Receptor Imaging in Acute Myocarditis and Cardiac Sarcoidosis
Official Title
Somatostatin Receptor Imaging in Inflammatory Heart Disease
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 20, 2020 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vastra Gotaland Region
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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) 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myocarditis, Cardiac Sarcoidosis
Keywords
Myocarditis, Cardiac sarcoidosis, Inflammatory cardiomyopathy, Cardiomyopathy, Heart disease, Cardiovascular disease, Somatostatin, 68Ga-DOTA-TOC, Positron emission tomography
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Acute myocarditis
Arm Type
Experimental
Arm Description
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.
Arm Title
Cardiac sarcoidosis
Arm Type
Experimental
Arm Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
68Ga-DOTA-TOC PET/CT
Intervention Description
Somatostatin receptor imaging
Intervention Type
Biological
Intervention Name(s)
Blood sample
Intervention Description
Analysis of inflammatory biomarkers
Primary Outcome Measure Information:
Title
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
Title
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
Title
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
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Entela Bollano, MD, PhD
Phone
+46-31-3421000
Email
entela.bollano@vgregion.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christian L Polte, MD, PhD, MSc
Organizational Affiliation
Sahlgrenska University Hospital, Sweden
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sahlgrenska University Hospital
City
Göteborg
ZIP/Postal Code
413 45
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Niklas Bergh, MD, PhD
Phone
+46-31-3421000
Email
niklas.bergh@vgregion.se
First Name & Middle Initial & Last Name & Degree
Christian L Polte, MD, PhD, MSc
Phone
+46-31-3421000
Email
christian.polte@vgregion.se
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Somatostatin Receptor Imaging in Acute Myocarditis and Cardiac Sarcoidosis
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