Status:

RECRUITING

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

Lead Sponsor:

John O. Prior

Conditions:

Acute Cellular Graft Rejection

Cardiac Sarcoidosis

Eligibility:

All Genders

18+ years

Phase:

PHASE2

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 sy...

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

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

Key Trial Info

Start Date :

January 17 2023

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

January 1 2026

Estimated Enrollment :

69 Patients enrolled

Trial Details

Trial ID

NCT05499637

Start Date

January 17 2023

End Date

January 1 2026

Last Update

December 30 2024

Active Locations (1)

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1

Centre Hospitalier Universitaire Vaudois

Lausanne, Canton of Vaud, Switzerland, 1011