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Recruiting NCT05499637

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

Phase II Interventional Acute Cellular Graft Rejection Cardiac Sarcoidosis Myocarditis Due to Drug

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: [68Ga]Ga-PentixaFor PET/CT.
Who it may be relevant to
Registry conditions: Acute Cellular Graft Rejection, Cardiac Sarcoidosis, Myocarditis Due to Drug. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Switzerland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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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

Overview

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

Interventions

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

Primary outcome measures

  • Imaging results obtained by [68Ga]Ga-PentixaFor PET/CT - lesion number [Time frame: 1 year]
  • Imaging results obtained by [68Ga]Ga-PentixaFor PET/CT - lesion site [Time frame: 1 year]
  • Imaging results obtained by [68Ga]Ga-PentixaFor PET/CT - SUV [Time frame: 1 year]
Secondary outcome measures (1)
  • to assess toxicity data [Time frame: 1 year]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Diagnostic

Study locations

Switzerland · 1 center
  • Centre Hospitalier Universitaire Vaudois — Lausanne

Identifiers

NCT: NCT05499637 · 2022-00425

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗