[68Ga]Ga-PentixaFor PET/CT in Acute Myocardial Inflammation
Switzerland69 participantsStarted 2023-01-17
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* signed written informed consent
* male or female
* age ≥ 18 years
* patients with suspicion CS (group II) or ICIM (group III) or in their regular follow-up in their first year after HT (group I)
* SOC clinical follow-up at the cardiology department in CHUV.
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:
* clinically unstable brady-tachyarrhythmia
* severe and symptomatic hypo- or hypertension with documented systolic blood pressure \< 90 mmHg or ≥220 mmHg respectively
* cardiogenic shock.
* 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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Imaging results obtained by [68Ga]Ga-PentixaFor PET/CT - lesion number
Timeframe: 1 year
2
Imaging results obtained by [68Ga]Ga-PentixaFor PET/CT - lesion site
Timeframe: 1 year
3
Imaging results obtained by [68Ga]Ga-PentixaFor PET/CT - SUV