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

Cardiac Sarcoidosis Clinical Trial

Official title:

Pilot Study to Evaluate the Accuracy of [68Ga]Ga-PentixaFor PET/CT in the Diagnosis of Three Clinical Entities of Acute Myocardial Inflammation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05499637
• Other study ID #: 2022-00425
• Status: Recruiting
• Phase: Phase 2
• Start date: January 17, 2023
• Est. completion date: January 2025

Study information

• Verified date: July 2023
• Source: University of Lausanne Hospitals
• Contact: John O Prior, MD, PhD
• Phone: +44795568702
• Email: john.prior[@]chuv.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 69
• Est. completion date: January 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Cellular Graft Rejection
• Cardiac Sarcoidosis
• Inflammation
• Myocarditis
• Sarcoidosis

Intervention

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

Locations

Country	Name	City	State
Switzerland	Centre Hospitalier Universitaire Vaudois	Lausanne	Vaud

Sponsors (1)

Lead Sponsor	Collaborator
John O. Prior

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Imaging results obtained by [68Ga]Ga-PentixaFor PET/CT - lesion number	lesion number imaged	1 year
Primary	Imaging results obtained by [68Ga]Ga-PentixaFor PET/CT - lesion site	lesion sites imaged	1 year
Primary	Imaging results obtained by [68Ga]Ga-PentixaFor PET/CT - SUV	standard uptake value	1 year
Secondary	to assess toxicity data	analysis of collected AEs classified according to CTCAE version 5.0	1 year