[68Ga]Ga-PentixaFor PET/CT in Acute Myocardial Inflammation
NCT ID: NCT05499637
Last Updated: 2024-12-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
69 participants
INTERVENTIONAL
2023-01-17
2026-01-31
Brief Summary
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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
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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acute cellular cardiac allograft rejection
\[68Ga\]Ga-PentixaFor PET/CT
[68Ga]Ga-PentixaFor PET/CT
\[68Ga\]Ga-PentixaFor PET/CT
cardiac sarcoidosis
\[68Ga\]Ga-PentixaFor PET/CT
[68Ga]Ga-PentixaFor PET/CT
\[68Ga\]Ga-PentixaFor PET/CT
immune checkpoint inhibitor induced myocarditis
\[68Ga\]Ga-PentixaFor PET/CT
[68Ga]Ga-PentixaFor PET/CT
\[68Ga\]Ga-PentixaFor PET/CT
Interventions
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[68Ga]Ga-PentixaFor PET/CT
\[68Ga\]Ga-PentixaFor PET/CT
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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John O. Prior
OTHER
Responsible Party
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John O. Prior
Head of Nuclear Medicine and Molecular Imaging Department, MD, PhD
Principal Investigators
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John O Prior, MD, PhD
Role: STUDY_CHAIR
University of Lausanne Hospitals
Locations
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Centre Hospitalier Universitaire Vaudois
Lausanne, Canton of Vaud, Switzerland
Countries
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Central Contacts
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Christel Kamani, MD
Role: CONTACT
Facility Contacts
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John O. Prior, MD, PhD
Role: primary
John O. Prior, MD, PhD
Role: backup
Other Identifiers
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2022-00425
Identifier Type: -
Identifier Source: org_study_id