Using a new imaging technique to diagnose heart inflammation

Pilot Study to Evaluate the Accuracy of [68Ga]Ga-PentixaFor PET/CT in the Diagnosis of Three Clinical Entities of Acute Myocardial Inflammation

This study is testing a new imaging method to see if it can help doctors diagnose heart inflammation in people with conditions like myocarditis and cardiac sarcoidosis.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 69 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University of Lausanne Hospitals (other)
• Locations: 1 site (Lausanne, Canton of Vaud)
• Trial ID: NCT05499637 on ClinicalTrials.gov

What this trial studies

This study investigates the effectiveness of [68Ga]Ga-PentixaFor PET/CT imaging in diagnosing acute myocardial inflammation, focusing on conditions such as acute cellular cardiac allograft rejection, cardiac sarcoidosis, and myocarditis due to immune checkpoint inhibitors. The study aims to correlate the accumulation of this imaging agent with established diagnostic methods to enhance non-invasive diagnosis. Participants will receive an intravenous injection of PentixaFor before undergoing PET/CT imaging to assess the presence of inflammatory cells in the heart.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with suspected cardiac sarcoidosis, immune checkpoint inhibitor-induced myocarditis, or those in the first year of follow-up after heart transplantation.

Not a fit: Patients with unstable cardiovascular conditions or those under 18 years old may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved non-invasive diagnostic methods for patients with acute myocardial inflammation.

How similar studies have performed: While the approach is innovative, similar studies have shown promise in using advanced imaging techniques for diagnosing cardiac conditions.

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

Where this trial is running

Lausanne, Canton of Vaud

• Centre Hospitalier Universitaire Vaudois — Lausanne, Canton of Vaud, Switzerland (RECRUITING)

Study contacts

• Study coordinator: John O Prior, MD, PhD

Conditions: Acute Cellular Graft Rejection, Cardiac Sarcoidosis, Myocarditis Due to Drug