[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

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05499637

Enrollment

Registered

2022-08-12

Start date

2023-01-17

Completion date

2027-01-01

Last updated

2026-05-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Brief 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

Interventions

DRUG[68Ga]Ga-PentixaFor PET/CT

\[68Ga\]Ga-PentixaFor PET/CT

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Imaging results obtained by [68Ga]Ga-PentixaFor PET/CT - lesion number	1 year	lesion number imaged
Imaging results obtained by [68Ga]Ga-PentixaFor PET/CT - lesion site	1 year	lesion sites imaged
Imaging results obtained by [68Ga]Ga-PentixaFor PET/CT - SUV	1 year	standard uptake value

Secondary

Measure	Time frame	Description
to assess toxicity data	1 year	analysis of collected AEs classified according to CTCAE version 5.0

Countries

Switzerland

Contacts

CONTACTJohn O Prior, MD, PhD

john.prior@chuv.ch+44795568702

CONTACTChristel Kamani, MD

STUDY_CHAIRJohn O Prior, MD, PhD

University of Lausanne Hospitals

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 12, 2026