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