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

Sponsor
M.D. Anderson Cancer Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT05062395
Collaborator
(none)
30
Enrollment
1
Location
14
Anticipated Duration (Months)
2.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or DiseaseIntervention/TreatmentPhase
  • Procedure: Computed Tomography
  • Other: Fludeoxyglucose F-18
  • Other: Low Carbohydrate High Fat Diet
  • Procedure: Positron Emission Tomography

Detailed Description

PRIMARY OBJECTIVE:
  1. 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:
  1. 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.

  2. 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).

  3. 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.

  4. 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.

  5. 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 Design

Study Type:
Observational
Anticipated Enrollment :
30 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Positron Emission Tomography for the Diagnosis of Immune Checkpoint Inhibitor-Related Myocarditis
Actual Study Start Date :
Mar 30, 2021
Anticipated Primary Completion Date :
May 31, 2022
Anticipated Study Completion Date :
May 31, 2022

Arms and Interventions

ArmIntervention/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:
  • CAT
  • CAT Scan
  • Computerized Axial Tomography
  • Computerized Tomography
  • CT
  • CT Scan
  • tomography
  • Other: Fludeoxyglucose F-18
    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
  • 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
  • Outcome Measures

    Primary Outcome Measures

    1. Sensitivity, specificity, positive predictive value, and negative predictive value [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1M D Anderson Cancer CenterHoustonTexasUnited States77030

    Sponsors and Collaborators

    • M.D. Anderson Cancer Center

    Investigators

    • Principal Investigator: Nicolas L Palaskas, MD, M.D. Anderson Cancer Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    M.D. Anderson Cancer Center
    ClinicalTrials.gov Identifier:
    NCT05062395
    Other Study ID Numbers:
    • 2020-0206
    • NCI-2021-00838
    • 2020-0206
    First Posted:
    Sep 30, 2021
    Last Update Posted:
    Sep 30, 2021
    Last Verified:
    Sep 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Sep 30, 2021