RECRUITING

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

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Conditions

Subclinical Immune Checkpoint Inhibitor-Induced MyocarditisMyocarditisICI-MyocarditisSolid Malignant TumorHematologic MalignancySubclinical MyocarditisSubclinical ICI-myocarditis

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

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

Quick Facts

Study Start:2024-10-11
Study Completion:2027-04-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06566209

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age ≥18 years at the time of signing informed consent
  2. * Any solid or hematologic malignancy undergoing treatment with ICI (either as a single agent or in combination with others)
  3. * 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.
  4. * Willing to return to Mayo Clinic for ongoing follow-up
  5. * Elevated troponin T levels (≥100 ng/L)
  6. * Left ventricular ejection fraction (LVEF) ≥50%
  7. * 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.
  1. * Chest pain
  2. * Fulminant myocarditis requiring steroid therapy
  3. * Cardiac MRI (CMR) with evidence of inflammation
  4. * On high doses of steroid treatment for other causes
  5. * 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).
  6. * Patients unable to provide informed consent
  7. * Patients unable to complete the diet preparation protocol
  8. * 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)
  9. * Breastfeeding

Contacts and Locations

Study Contact

Clinical Trials Referral Office
CONTACT
855-776-0015
mayocliniccancerstudies@mayo.edu

Principal Investigator

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

Study Locations (Sites)

Mayo Clinic in Rochester
Rochester, Minnesota, 55905
United States

Collaborators and Investigators

Sponsor: Mayo Clinic

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

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 Registration Dates

Study Start Date2024-10-11
Study Completion Date2027-04-30

Study Record Updates

Study Start Date2024-10-11
Study Completion Date2027-04-30

Terms related to this study

Additional Relevant MeSH Terms

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