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

May 5, 2026 updated by: Mayo Clinic

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

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.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Device: Fluorodeoxyglucose - Positron Emission Tomography (FDG-PET)
Receive 18F-FDG PET/CT
Other Names:
  • FDG-PET
  • Computed Tomography
  • Positron Emission Tomography
  • 18F-fluorodeoxyglucose positron emission tomography
  • Positron Emission Tomography-Computed Tomography (PET/CT)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Presennce of inflammation or scarring
Time Frame: Baseline; Up to 7 months
Assessed by reviewing 18F-FDG PET/CT imaging for presence of inflammation, progression/regression of inflammation or scarring.
Baseline; Up to 7 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of hospitalization
Time Frame: Up to 2 years
Assessed by review of medical record for incidence of hospitalization
Up to 2 years
Cardiovascular Intensive Care Unit (CICU) Level of Care Days
Time Frame: Up to 2 years
Assessed by reviewing medical record for number of days, if any, of CICU care.
Up to 2 years
Incidence of arrhythmias
Time Frame: Up to 2 years
Assessed by reviewing medical record for incidence of cardiac arrhythmias.
Up to 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Martin G. Rodriguez-Porcel, MD, Mayo Clinic in Rochester

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 11, 2024

Primary Completion (Actual)

December 22, 2025

Study Completion (Actual)

December 22, 2025

Study Registration Dates

First Submitted

August 20, 2024

First Submitted That Met QC Criteria

August 20, 2024

First Posted (Actual)

August 22, 2024

Study Record Updates

Last Update Posted (Actual)

May 8, 2026

Last Update Submitted That Met QC Criteria

May 5, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 24-001222
  • NCI-2024-06871 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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