FDG-PET as an Imaging Modality to Diagnose and Risk Stratify Subclinical, Imaging Negative Ici-Myocarditis
NCT ID: NCT06566209
Last Updated: 2025-10-15
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
30 participants
OBSERVATIONAL
2024-10-11
2027-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Experimental FDG PET/CT
Patients undergo 18F-FDG and 13N-ammonia PET/CT scan, blood sample collection and have their medical records reviewed on study.
Fluorodeoxyglucose - Positron Emission Tomography (FDG-PET)
Receive 18F-FDG PET/CT
Interventions
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Fluorodeoxyglucose - Positron Emission Tomography (FDG-PET)
Receive 18F-FDG PET/CT
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Any solid or hematologic malignancy undergoing treatment with ICI (either as a single agent or in combination with others)
* Ambulatory and able to complete a 48-72 hour high fat and low carbohydrate diet with 18 hours fasting (PET diet), 18F-FDG PET/CT scanning, as well as 13N-ammonia PET-CT myocardial perfusion imaging (part of the routine protocol of the investigation). These two studies will be done as part of the same imaging set.
* Willing to return to Mayo Clinic for ongoing follow-up
* Left ventricular ejection fraction (LVEF) ≥45%
* Cardiac MRI (CMR) without conclusive evidence of inflammation, coronary assessment available (either via cardiac computed tomography angiography, CCTA, or via coronary angiogram) Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial.
Exclusion Criteria
* CMR with definitive evidence of myocarditis
* Clinical presentation consistent with acute coronary syndrome (wall motion abnormalities consistent with a specific coronary distribution, coronary angiogram with a culprit lesion identified, patients requiring revascularization either with percutaneous coronary interventions or coronary artery bypass grafting).
* Patients unable to provide informed consent
* Patients unable to complete the diet preparation protocol
* Pregnancy (all women of child-bearing age and potential will have a negative pregnancy test within 48 hours of the PET/CT at screen and 6-month visit)
* Breastfeeding
18 Years
ALL
No
Sponsors
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Mayo Clinic
OTHER
Responsible Party
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Principal Investigators
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Martin G. Rodriguez-Porcel, MD
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic in Rochester
Locations
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Mayo Clinic in Rochester
Rochester, Minnesota, United States
Countries
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Central Contacts
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Facility Contacts
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Related Links
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Mayo Clinic Clinical Trials
Other Identifiers
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NCI-2024-06871
Identifier Type: REGISTRY
Identifier Source: secondary_id
24-001222
Identifier Type: -
Identifier Source: org_study_id
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