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

John O. Prior

Status and phase: Enrolling; Phase 2

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

Treatments: Drug: [68Ga]Ga-PentixaFor PET/CT

Study type: Interventional

Funder types: Other

Identifiers

NCT05499637

2022-00425

Details and patient eligibility

About

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.

Full 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

Enrollment: 69 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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 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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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69 participants in 3 patient groups

acute cellular cardiac allograft rejection

Experimental group

Description:

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

Treatment:

Drug: [68Ga]Ga-PentixaFor PET/CT

cardiac sarcoidosis

Experimental group

Description:

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

Treatment:

Drug: [68Ga]Ga-PentixaFor PET/CT

immune checkpoint inhibitor induced myocarditis

Experimental group

Description:

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

Treatment:

Drug: [68Ga]Ga-PentixaFor PET/CT