[68Ga]Ga-PentixaFor PET/CT in Acute Myocardial Inflammation

Launched by JOHN O. PRIOR · Aug 11, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a special imaging technique called \[68Ga\]Ga-PentixaFor PET/CT to help diagnose acute myocardial inflammation, which is a condition affecting the heart that can occur in various diseases like acute cellular graft rejection, cardiac sarcoidosis, and myocarditis caused by certain cancer treatments. The goal is to see if this imaging method can accurately identify inflammation in the heart early on, which is important for effective treatment.

To participate in the trial, you need to be at least 18 years old and have a suspicion of one of the conditions mentioned or be in your first year of follow-up after heart transplant. You also need to provide written consent to join the study. If you enroll, you can expect to undergo some imaging tests, and the results will be compared with standard diagnostic tools to see how well they match. It’s important to know that there are some conditions that would exclude you from participating, such as being pregnant, having certain severe health issues, or being unable to understand the study procedures.

Gender

ALL

Eligibility criteria

• 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 to follow procedures
• • the patient makes use of his/her "right not to know" and refuses to be informed about incidental findings