Clinical trial NCT05062395: Positron Emission Tomography for the Diagnosis of Immune Checkpoint Inhibitor-Related Myocarditis
Official title: Positron Emission Tomography for the Diagnosis of Immune Checkpoint Inhibitor-Related Myocarditis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Myocarditis Acute
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2021-09-30
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients being treated with ICI and presenting to the University of Texas MD Anderson Cancer Center (MDACC) with suspected ICI-related myocarditis

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Sensitivity, specificity, positive predictive value, and negative predictive value
timeFrame: through study completion, an average of a year.
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Nicolas L Palaskas, MD
role: PRINCIPAL_INVESTIGATOR
References: