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

Phase 2

Recruiting

• Conditions: Cardiac Sarcoidosis; Acute Cellular Graft Rejection; Myocarditis Due to Drug
• Interventions: Drug: [68Ga]Ga-PentixaFor PET/CT

• Registration Number: NCT05499637
• Lead Sponsor: John O. Prior

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

Study Timeline

• Study First Submitted: 2022-06-22
• Study First Submitted QC: 2022-08-11
• Study First Posted: 2022-08-12
• Study Start: 2023-01-17
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-24
• Last Update Posted: 2024-12-30
• Primary Completion: 2025-12
• Study Completion: 2026-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 69

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
acute cellular cardiac allograft rejection	[68Ga]Ga-PentixaFor PET/CT	\[68Ga\]Ga-PentixaFor PET/CT
immune checkpoint inhibitor induced myocarditis	[68Ga]Ga-PentixaFor PET/CT	\[68Ga\]Ga-PentixaFor PET/CT
cardiac sarcoidosis	[68Ga]Ga-PentixaFor PET/CT	\[68Ga\]Ga-PentixaFor PET/CT

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
to assess toxicity data	1 year	analysis of collected AEs classified according to CTCAE version 5.0

Trial Locations

Locations (1)

Centre Hospitalier Universitaire Vaudois; 🇨🇭 Lausanne, Vaud, Switzerland