Actively Recruiting
Pilot Study to Evaluate the Accuracy of [68Ga]Ga-PentixaFor PET/CT in Diagnosing Three Types of Acute Myocardial Inflammation
Led by John O. Prior · Updated on 2026-05-11
69
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating acute myocardial inflammation, a complex condition that includes acute cellular cardiac allograft rejection (ACR), cardiac sarcoidosis (CS), and immune checkpoint inhibitor induced myocarditis (ICIM). This study aims to evaluate the accuracy of [68Ga]Ga-PentixaFor PET/CT imaging for detecting inflammatory cells in these patients, offering a potentially non-invasive diagnostic option. The study is a phase 2 trial focusing on these specific heart inflammation conditions where diagnosis is currently challenging. Participants will receive an intravenous injection of a maximum of 50 micrograms of PentixaFor labeled with 150 ±15 MBq of Gallium-68 ([68Ga]) as a bolus 60 ±15 minutes before undergoing PET/CT imaging. The treatment involves this imaging procedure for all three patient groups (ACR, CS, ICIM) to assess the presence and characteristics of myocardial inflammation. During the study, researchers will evaluate imaging results by analyzing lesion number, location, and standardized uptake value (SUV) over one year. They will also monitor toxicity data for safety assessment. Participants will have regular clinical follow-ups at the cardiology department. The study involves signing informed consent and includes monitoring for any adverse effects related to the imaging agent or procedures throughout the study duration.
CONDITIONS
Brief Title
[68Ga]Ga-PentixaFor PET/CT in Acute Myocardial Inflammation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed written informed consent
- Male or female
- Age 18 years or older
- Patients suspected of cardiac sarcoidosis or immune checkpoint inhibitor induced myocarditis, or in first year after heart transplantation
- Receiving standard clinical follow-up at the cardiology department
You will not qualify if you...
- No signed written informed consent
- Age under 18 years
- Claustrophobia
- Myocardial ischemia detected by non-invasive perfusion test or coronary angiography in cardiac sarcoidosis or immune checkpoint inhibitor induced myocarditis groups
- Clinically unstable cardiovascular conditions including unstable brady-tachyarrhythmia, severe hypo- or hypertension with systolic blood pressure below 90 mmHg or above 220 mmHg, or cardiogenic shock
- Pregnant or breastfeeding women
- Planning pregnancy during the study in cardiac sarcoidosis group
- Previous enrollment in this study
- Moderate to severe renal insufficiency with contraindication to gadolinium in cardiac sarcoidosis or immune checkpoint inhibitor induced myocarditis groups
- Investigator, family members, employees, or dependent persons enrolled
- Any disease or condition interfering with study objectives as judged by investigator
- Insufficient knowledge of project language or inability to consent or follow procedures
- Refusal to be informed about incidental findings by exercising "right not to know"
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single day procedure
Participants receive an injection of [68Ga]Ga-PentixaFor followed by PET/CT imaging to diagnose acute myocardial inflammation.
1 visit (in-person)
Duration - 1 year
Participants are monitored for imaging results and toxicity over the following year.
Follow-up visits as needed during 1 year
Trial Site Locations
Total: 1 location
1
Centre Hospitalier Universitaire Vaudois
Lausanne, Canton of Vaud, Switzerland, 1011
Actively Recruiting
Research Team
J
John O Prior, MD, PhD
C
Christel Kamani, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
3
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