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

NCT06566209 | Terminated FDA Device

• 1 other identifier: 24-001222
• Study Type: observational
• Target: 2
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Outcome Measures

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.

  Baseline; Up to 7 months

Secondary Outcomes (3)

• Incidence of hospitalization

  Up to 2 years

• Cardiovascular Intensive Care Unit (CICU) Level of Care Days

  Up to 2 years

• Incidence of arrhythmias

  Up to 2 years

Study Arms (1)

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

Fluorodeoxyglucose - Positron Emission Tomography (FDG-PET) DEVICE

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)

Experimental FDG PET/CT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Myocarditis; Hematologic Neoplasms

Interventions

Positron-Emission Tomography; Tomography, X-Ray Computed; Positron Emission Tomography Computed Tomography

Condition Hierarchy (Ancestors)

Cardiomyopathies; Heart Diseases; Cardiovascular Diseases; Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Tomography, Emission-Computed; Image Interpretation, Computer-Assisted; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Image Enhancement; Photography; Radionuclide Imaging; Tomography; Diagnostic Techniques, Radioisotope; Radiographic Image Enhancement; Radiography; Tomography, X-Ray; Multimodal Imaging

Study Officials

• Martin G. Rodriguez-Porcel, MD

  Mayo Clinic in Rochester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2024
• First Posted: August 22, 2024
• Study Start: October 11, 2024
• Primary Completion: December 22, 2025
• Study Completion: December 22, 2025
• Last Updated: May 8, 2026

Record last verified: 2026-05

Locations

US (1)