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TerminatedNCT06566209Updated May 8, 2026

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

An observational study in Subclinical Immune Checkpoint Inhibitor-Induced Myocarditis, Myocarditis and ICI-Myocarditis, sponsored by Mayo Clinic. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-08.

Sponsored by Mayo Clinic · Observational

Why this study was terminated
Low/slow accrual (change in standard treatment practice)
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
2
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Subclinical Immune Checkpoint Inhibitor-Induced Myocarditis
  • Myocarditis
  • ICI-Myocarditis
  • Solid Malignant Tumor
  • Hematologic Malignancy
  • Subclinical Myocarditis
  • Subclinical ICI-myocarditis
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In context

Myocarditis

164 studies on the registry are indexed under Myocarditis; 71 are open to participants now.

This study's enrollment of 2 is below the median of 226 across 115 observational studies indexed under Myocarditis.

Browse Myocarditis studies →

Lead sponsor

Mayo Clinic is the lead sponsor of 3,218 studies on the registry; 670 are open to participants now.

Of its 445 completed or terminated interventional studies of FDA-regulated products, 313 (70%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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.

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

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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
2 participants (actual)
Patient registry
No

Groups and cohorts

  • 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)

Interventions

  • DeviceFluorodeoxyglucose - Positron Emission Tomography (FDG-PET)

    Receive 18F-FDG PET/CT

    Also known as: 18F-fluorodeoxyglucose positron emission tomography, Positron Emission Tomography, Computed Tomography, FDG-PET, Positron Emission Tomography-Computed Tomography (PET/CT)

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What researchers measure

Primary outcomes

  1. Presennce of inflammation or scarring

    Assessed by reviewing 18F-FDG PET/CT imaging for presence of inflammation, progression/regression of inflammation or scarring.

    Time frame: Baseline; Up to 7 months

Secondary outcomes

  1. Incidence of hospitalization

    Assessed by review of medical record for incidence of hospitalization

    Time frame: Up to 2 years

  2. Cardiovascular Intensive Care Unit (CICU) Level of Care Days

    Assessed by reviewing medical record for number of days, if any, of CICU care.

    Time frame: Up to 2 years

  3. Incidence of arrhythmias

    Assessed by reviewing medical record for incidence of cardiac arrhythmias.

    Time frame: Up to 2 years

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Study locations

1 site
  • Mayo Clinic in Rochester
    Rochester, Minnesota 55905, United States
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References and documents

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 8, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06566209
Lead sponsor
Mayo Clinic
Responsible party
Sponsor
First posted
Aug 22, 2024
Start date
Oct 11, 2024
Primary completion
Dec 22, 2025
Completion
Dec 22, 2025
Last update
May 8, 2026

Study contacts

Martin G. Rodriguez-Porcel, MD
principal investigator · Mayo Clinic in Rochester

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in May 2026. You cannot join it, but the record below documents what was studied.

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