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

NCT05499637 | Recruiting Phase 2

• 1 other identifier: 2022-00425
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• to assess toxicity data

  1 year

Study Arms (3)

acute cellular cardiac allograft rejection

EXPERIMENTAL

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

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

cardiac sarcoidosis

EXPERIMENTAL

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

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

immune checkpoint inhibitor induced myocarditis

EXPERIMENTAL

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

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

Interventions

[68Ga]Ga-PentixaFor PET/CT DRUG

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

Also known as: no other intervention name

acute cellular cardiac allograft rejection; cardiac sarcoidosis; immune checkpoint inhibitor induced myocarditis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• John O. Prior: lead

Study Sites (1)

Centre Hospitalier Universitaire Vaudois

Lausanne, Canton of Vaud, 1011, Switzerland

RECRUITING

Study Officials

• John O Prior, MD, PhD

  University of Lausanne Hospitals

  STUDY CHAIR

Central Study Contacts

John O Prior, MD, PhD

CONTACT

+44795568702; john.prior@chuv.ch

Christel Kamani, MD

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of Nuclear Medicine and Molecular Imaging Department, MD, PhD

Study Record Dates

• First Submitted: June 22, 2022
• First Posted: August 12, 2022
• Study Start: January 17, 2023
• Primary Completion: December 1, 2025
• Study Completion: January 1, 2026
• Last Updated: December 30, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)