FDG-PET As an Imaging Modality to Diagnose and Risk Stratify Subclinical, Imaging Negative Ici-Myocarditis

Description

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.

Conditions

Subclinical Immune Checkpoint Inhibitor-Induced Myocarditis, Myocarditis, ICI-Myocarditis, Solid Malignant Tumor, Hematologic Malignancy, Subclinical Myocarditis, Subclinical ICI-myocarditis

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Study Overview

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Study Details

Study overview

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.

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

FDG-PET As an Imaging Modality to Diagnose and Risk Stratify Subclinical, Imaging Negative Ici-Myocarditis

Condition
Subclinical Immune Checkpoint Inhibitor-Induced Myocarditis
Intervention / Treatment

-

Contacts and Locations

Rochester

Mayo Clinic in Rochester, Rochester, Minnesota, United States, 55905

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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 2-day 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
  • * Elevated troponin T levels (≥100 ng/L)
  • * Left ventricular ejection fraction (LVEF) ≥50%
  • * Cardiac MRI (CMR) without 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.
  • * Chest pain
  • * Fulminant myocarditis requiring steroid therapy
  • * Cardiac MRI (CMR) with evidence of inflammation
  • * On high doses of steroid treatment for other causes
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Mayo Clinic,

Martin G. Rodriguez-Porcel, MD, PRINCIPAL_INVESTIGATOR, Mayo Clinic in Rochester

Study Record Dates

2027-04-30