Completed

NCT Number: NCT05062395

Positron Emission Tomography for the Diagnosis of Immune Checkpoint Inhibitor-Related Myocarditis

This study evaluates positron emission tomography for the diagnosis of immune checkpoint inhibitor-related myocarditis. Immune checkpoint inhibitors have shown promising results in various malignancies however, several immune related adverse events have been described of which myocarditis carries the highest reported mortality. Diagnostic procedures, such as positron emission tomography, help find and diagnose myocarditis and provide functional or disease activity information as opposed to the largely structural/anatomic information.

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Key information

Conditions

Myocarditis Acute

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

M D Anderson Cancer Center

Houston, Texas, 77030, United States

About this study

PRIMARY OBJECTIVE:

I. To prospectively evaluate the sensitivity, specificity, positive predictive value, and negative predictive value of fludeoxyglucose F-18 (18 fluorodeoxyglucose) positive emission tomography computed tomography (PET CT) for the diagnosis of immune checkpoint inhibitor (ICI) related myocarditis.

SECONDARY OBJECTIVES:

I. To explore the clinical presentation and disease course of ICI-related myocarditis which include presenting symptoms (chest pain, dyspnea, fatigue), time from ICI initiation to symptom onset, hospitalization duration, time to peak troponin levels, and peak troponin levels.

II. To evaluate biomarkers, including peak troponin, peak no probnp, admission troponin level, and admission nt probnp level, and imaging modalities of ICI-related myocarditis which include sensitivity, specificity, positive predictive value, and negative predictive value of cardiac magnetic resonance imaging (MRI).

III. To determine the response to various treatments of ICI-related myocarditis which include time to resolution of symptoms, hospitalization duration, and peak troponin value stratified by treatment.

IV. To observe the long-term outcomes, including late decline in left ventricular ejection fraction (LVEF) to < 50%, and survival after ICI related myocarditis, and monitoring of ICI-related myocarditis.

V. To assess differences in PET CT imaging results between patients on steroid therapy versus not on steroid therapy for myocarditis.

OUTLINE:

Patients receive a low carbohydrate and high fat diet for 48-72 hours. Patients receive 18 fluorodeoxyglucose (FDG) then undergo PET CT.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients of age >= 18 years
Patients must be able to understand and be willing to sign a written informed consent document. Surrogate decision-makers of patients will be allowed to consent patients for this study
Patients must be receiving or have a history of receiving any ICI therapy in monotherapy or combination therapy
Patients must have a suspicion of ICI-related myocarditis either by clinical presentation, biomarkers, or other diagnostic modalities

Exclusion criteria

Pregnant or lactating patients will be excluded

Treatment and study plan

Computed Tomography

Procedure

Undergo FDG PET CT

Other names: CAT, CAT Scan, Computerized Axial Tomography, Computerized Tomography, CT, CT Scan, tomography

Fludeoxyglucose F-18

Other

Undergo FDG PET CT

Other names: 18FDG, FDG, Fludeoxyglucose (18F), fludeoxyglucose F 18, Fludeoxyglucose F18, Fluorine-18 2-Fluoro-2-deoxy-D-Glucose, Fluorodeoxyglucose F18

Low carbohydrate high fat diet

Other

low carbohydrate and high fat diet for 48-72 hours

Positron Emission Tomography

Procedure

Undergo FDG PET CT

Other names: Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron Emission Tomography Scan, Positron-Emission Tomography, proton magnetic resonance spectroscopic imaging

Primary outcomes

Sensitivity, specificity, positive predictive value, and negative predictive value

Time frame: through study completion, an average of a year.

Calculations of sensitivity, specificity, positive predictive value, and negative predictive value and their 90% exact confidence intervals will be performed for the evaluation of positron emission tomography computed tomography considering endomyocardial biopsy as the gold standard. Secondary analysis of these parameters will be used considering the Bonaca et al diagnoses of immune checkpoint inhibitor (ICI)-related myocarditis as a new gold standard. Receiver operating characteristic (ROC) curve and the AUC value (area under the ROC curve) will be evaluated.

Sponsors and collaborators

Lead sponsor

M.D. Anderson Cancer Center

Other

Registry information

Important dates

Study start: 2021
Primary completion: 2023
Study completion: 2023
First posted: Sep 30, 2021
Registry last updated: Apr 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed