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

April 7, 2023 updated by: M.D. Anderson Cancer Center
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

13

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • M D Anderson Cancer Center

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.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Observational (diet, FDG PET CT)
Patients receive a low carbohydrate and high fat diet for 48-72 hours. Patients receive FDG then undergo PET CT.
Procedure: Computed Tomography
Undergo FDG PET CT
Other Names:
  • CT
  • CAT
  • CAT Scan
  • Computerized Axial Tomography
  • Computerized Tomography
  • CT Scan
  • tomography
Other: Fludeoxyglucose F-18
Undergo FDG PET CT
Other Names:
  • 18FDG
  • FDG
  • fludeoxyglucose F 18
  • Fludeoxyglucose (18F)
  • Fludeoxyglucose F18
  • Fluorine-18 2-Fluoro-2-deoxy-D-Glucose
  • Fluorodeoxyglucose F18
Other: Low Carbohydrate High Fat Diet
low carbohydrate and high fat diet for 48-72 hours
Procedure: Positron Emission Tomography
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
through study completion, an average of a year.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

M.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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 Major Dates

Study Start (Actual)

March 30, 2021

Primary Completion (Actual)

April 4, 2023

Study Completion (Actual)

April 4, 2023

Study Registration Dates

First Submitted

February 25, 2021

First Submitted That Met QC Criteria

September 21, 2021

First Posted (Actual)

September 30, 2021

Study Record Updates

Last Update Posted (Actual)

April 10, 2023

Last Update Submitted That Met QC Criteria

April 7, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-0206 (Other Identifier: M D Anderson Cancer Center)
  • NCI-2021-00838 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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