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
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Switzerland
Centre Hospitalier Universitaire Vaudois
RECRUITING
Lausanne
Contact Information
Primary
John O Prior, MD, PhD
john.prior@chuv.ch
+44795568702
Backup
Christel Kamani, MD
Time Frame
Start Date: 2023-01-17
Estimated Completion Date: 2026-01
Participants
Target number of participants: 69
Treatments
Experimental: acute cellular cardiac allograft rejection
\[68Ga\]Ga-PentixaFor PET/CT
Experimental: cardiac sarcoidosis
\[68Ga\]Ga-PentixaFor PET/CT
Experimental: immune checkpoint inhibitor induced myocarditis
\[68Ga\]Ga-PentixaFor PET/CT
Related Therapeutic Areas
Sponsors
Leads: John O. Prior

This content was sourced from clinicaltrials.gov