[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

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.

Study Overview

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

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 Type: Interventional
• Enrollment (Estimated): 69
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: John O Prior, MD, PhD; Phone Number: +44795568702; Email: john.prior@chuv.ch
• Study Contact Backup: Name: Christel Kamani, MD

Study Locations

• Switzerland
  • Canton of Vaud
    • Lausanne, Canton of Vaud, Switzerland, 1011
      • Recruiting
      • Centre Hospitalier Universitaire Vaudois
      • Contact: John O. Prior, MD, PhD; Phone Number: +41 (0)21-3144348; Email: john.prior@chuv.ch
      • Principal Investigator: John O. Prior, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: acute cellular cardiac allograft rejection; [68Ga]Ga-PentixaFor PET/CT	Drug: [68Ga]Ga-PentixaFor PET/CT; [68Ga]Ga-PentixaFor PET/CT; Other Names: no other intervention name
Experimental: cardiac sarcoidosis; [68Ga]Ga-PentixaFor PET/CT	Drug: [68Ga]Ga-PentixaFor PET/CT; [68Ga]Ga-PentixaFor PET/CT; Other Names: no other intervention name
Experimental: immune checkpoint inhibitor induced myocarditis; [68Ga]Ga-PentixaFor PET/CT	Drug: [68Ga]Ga-PentixaFor PET/CT; [68Ga]Ga-PentixaFor PET/CT; Other Names: no other intervention name

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: John O. Prior
• Investigators: Study Chair: John O Prior, MD, PhD, University of Lausanne Hospitals

Study record dates

Study Major Dates

• Study Start (Actual): January 17, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: June 22, 2022
• First Submitted That Met QC Criteria: August 11, 2022
• First Posted (Actual): August 12, 2022

Study Record Updates

• Last Update Posted (Actual): May 11, 2026
• Last Update Submitted That Met QC Criteria: May 5, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Immune System Diseases; Hypersensitivity; Cardiomyopathies; Lymphatic Diseases; Lymphoproliferative Disorders; Hypersensitivity, Delayed; Myocarditis; Inflammation; Sarcoidosis
• Other Study ID Numbers: 2022-00425

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No