Clinical trial NCT06566209: FDG-PET as an Imaging Modality to Diagnose and Risk Stratify Subclinical, Imaging Negative Ici-Myocarditis
Official title: Positron Emission Tomography for the Detection of Subclinical Immune Checkpoint Inhibitor-Induced Myocarditis (PET-SIM): A Prospective, Single Center, Single Arm, Open Label Pilot Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Subclinical Immune Checkpoint Inhibitor-Induced Myocarditis
Myocarditis
ICI-Myocarditis
Solid Malignant Tumor
Hematologic Malignancy
Subclinical Myocarditis
Subclinical ICI-myocarditis
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2024-08-22
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult male or female patients diagnosed with having a solid tumor or cancers in the blood and who are undergoing treatment with immune checkpoint inhibitors (ICI) either as a single agent or in combination with others.

Brief summary: The purpose of this pilot study is to evaluate Fluorodeoxyglucose - Positron Emission Tomography (FDG-PET) as an imaging modality to diagnose and risk stratify subclinical, imaging negative ICI-myocarditis, and to determine whether subclinical ICI-induced myocarditis is a distinct and clinically relevant entity with a risk of progression to fulminant myocarditis.


Eligibility criteria: Inclusion Criteria:

* Age ≥18 years at the time of signing informed consent
* 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:

* Fulminant myocarditis requiring steroid therapy
* 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

Primary outcomes:
measure: Presennce of inflammation or scarring
timeFrame: Baseline; Up to 7 months
Secondary outcomes:
measure: Incidence of hospitalization
timeFrame: Up to 2 years
measure: Cardiovascular Intensive Care Unit (CICU) Level of Care Days
timeFrame: Up to 2 years
measure: Incidence of arrhythmias
timeFrame: Up to 2 years
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic in Rochester
name: Martin G. Rodriguez-Porcel, MD
role: PRINCIPAL_INVESTIGATOR
References: