Somatostatin Receptor Imaging in Acute Myocarditis and Cardiac Sarcoidosis

NCT ID: NCT04206163

Last Updated: 2024-09-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

78 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-20

Study Completion Date

2024-06-24

Brief Summary

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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.

Detailed Description

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Conditions

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Acute Myocarditis Cardiac Sarcoidosis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Acute myocarditis

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.

Group Type EXPERIMENTAL

68Ga-DOTA-TOC PET/CT

Intervention Type DIAGNOSTIC_TEST

Somatostatin receptor imaging

Blood sample

Intervention Type BIOLOGICAL

Analysis of inflammatory biomarkers

Cardiac sarcoidosis

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.

Group Type EXPERIMENTAL

68Ga-DOTA-TOC PET/CT

Intervention Type DIAGNOSTIC_TEST

Somatostatin receptor imaging

Blood sample

Intervention Type BIOLOGICAL

Analysis of inflammatory biomarkers

Interventions

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68Ga-DOTA-TOC PET/CT

Somatostatin receptor imaging

Intervention Type DIAGNOSTIC_TEST

Blood sample

Analysis of inflammatory biomarkers

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Vastra Gotaland Region

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Christian L Polte, MD, PhD, MSc

Role: PRINCIPAL_INVESTIGATOR

Sahlgrenska University Hospital

Locations

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Sahlgrenska University Hospital

Gothenburg, , Sweden

Site Status

Countries

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Sweden

Other Identifiers

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2019-001300-38

Identifier Type: -

Identifier Source: org_study_id

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