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

Overview

About this study

The purpose of this study is to evaluate 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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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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 FDG-PET scanning.
  • Willing to return to Mayo clinic for ongoing follow-up.
  • Elevated troponin T levels (≥100 ng/L).
  • 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.

Exclusion Criteria:

  • 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 PET diet and fasting protocol.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 1/31/24. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Martin Rodriguez-Porcel, M.D.

Open for enrollment

Contact information:

Preventive Heart Research Team

(507) 538-7425

RSTCRVRUPREVENT@mayo.edu

More information

Publications

Publications are currently not available