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New treatment option for Acute Cellular Graft Rejection
Official title [68Ga]Ga-PentixaFor PET/CT in Acute Myocardial Inflammation
ClinicalTrials.gov ID: NCT05499637
What this study is testing
What is [68Ga]Ga-PentixaFor PET/CT?
[68Ga]Ga-PentixaFor PET/CT is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for acute cellular graft rejection.
Also referred to as no other intervention name.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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.
You likely can't join if
- 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:
See the full eligibility 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.
- 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 to follow procedures
- the patient makes use of his/her "right not to know" and refuses to be informed about incidental findings
The study team makes the final eligibility decision.
Where it's taking place
- Lausanne, Canton of Vaud, Switzerland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Lausanne, Canton of Vaud, Switzerland. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.