NCT05499637

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

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 69 (estimated)
• Sponsor: John O. Prior · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Imaging will consist of administration of maximum 50 µg IV PentixaFor, labelled with 150 ±15 MBq of 68Ga, as bolus injection 60 ±15 minutes prior PET/CT

Conditions

• Acute Cellular Graft Rejection
• Cardiac Sarcoidosis
• Myocarditis Due to Drug

Interventions

Type	Name	Description
DRUG	[68Ga]Ga-PentixaFor PET/CT	\[68Ga\]Ga-PentixaFor PET/CT

Timeline

• Start date: 2023-01-17
• Primary completion: 2025-12-01
• Completion: 2026-01-01
• First posted: 2022-08-12
• Last updated: 2024-12-30

Locations

1 site across 1 country: Switzerland