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Acute myocardial inflammation is an heterogenic syndrome involving different clinical pathologies with different outcome. For the purpose of this study protocol, we focuse on three entities of this syndrome, namely the acute cellular cardiac allograft rejection (ACR), cardiac sarcoidosis (CS) and the immune checkpoint inhibitor induced myocarditis (ICIM), for which non-invasive diagnosis remains challenging.
Since accurate diagnosis of myocardial inflammation in an early stage is crucial, this study aims to investigate the accuracy of [68Ga]Ga-PentixaFor as a marker of for the presence of inflammatory cells (T-lymphocytes and M1) in described patients.
The identification of a correlation between [68Ga]Ga-PentixaFor myocardial accumulation with currently accepted diagnostic tools would open up new ways to non-invasively diagnose acute myocardial inflammation.
Imaging will consist of administration of maximum 50 µg IV PentixaFor, labelled with 150 ±15 MBq of 68Ga, as bolus injection 60 ±15 minutes prior PET/CT
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| acute cellular cardiac allograft rejection | Experimental | [68Ga]Ga-PentixaFor PET/CT |
|
| cardiac sarcoidosis | Experimental | [68Ga]Ga-PentixaFor PET/CT |
|
| immune checkpoint inhibitor induced myocarditis | Experimental | [68Ga]Ga-PentixaFor PET/CT |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [68Ga]Ga-PentixaFor PET/CT | Drug | [68Ga]Ga-PentixaFor PET/CT |
|
| Measure | Description | Time Frame |
|---|---|---|
| Imaging results obtained by [68Ga]Ga-PentixaFor PET/CT - lesion number | lesion number imaged | 1 year |
| Imaging results obtained by [68Ga]Ga-PentixaFor PET/CT - lesion site | lesion sites imaged | 1 year |
| Imaging results obtained by [68Ga]Ga-PentixaFor PET/CT - SUV | standard uptake value | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| to assess toxicity data | analysis of collected AEs classified according to CTCAE version 5.0 | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
The presence of any one of the following exclusion criteria will lead to exclusion of the participant:
absence of a signed written informed consent
patients aged < 18 years
claustrophobia
myocardial ischemia in non-invasive perfusion test or coronarography in group II and III
clinically unstable cardiovascular conditions, including:
women who are pregnant or breast feeding
intention to become pregnant during the course of the study in group II
previous enrolment into the current study
moderate to severe renal insufficiency (GFR < 45 mL/min/1,73 m2), with contra-indication to the administration of Gadolinium in group II and III
enrollment of the investigator, his/her family members, employees and other dependent persons
history of any disease or relevant physical or psychiatric condition or abnormal physical finding which may interfere with the study objectives at the investigator judgment
insufficient knowledge of project language, inability to give consent or to follow procedures
the patient makes use of his/her "right not to know" and refuses to be informed about incidental findings
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| John O Prior, MD, PhD | Contact | +44795568702 | john.prior@chuv.ch | |
| Christel Kamani, MD | Contact |
| Name | Affiliation | Role |
|---|---|---|
| John O Prior, MD, PhD | University of Lausanne Hospitals | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier Universitaire Vaudois | Recruiting | Lausanne | Canton of Vaud | 1011 | Switzerland |
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