Positron Emission Tomography for the Diagnosis of Immune Checkpoint Inhibitor-Related Myocarditis
NCT ID: NCT05062395
Last Updated: 2023-04-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
13 participants
OBSERVATIONAL
2021-03-30
2023-04-04
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
Computed Tomography
Undergo FDG PET CT
Fludeoxyglucose F-18
Undergo FDG PET CT
Low Carbohydrate High Fat Diet
low carbohydrate and high fat diet for 48-72 hours
Positron Emission Tomography
Undergo FDG PET CT
Interventions
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Computed Tomography
Undergo FDG PET CT
Fludeoxyglucose F-18
Undergo FDG PET CT
Low Carbohydrate High Fat Diet
low carbohydrate and high fat diet for 48-72 hours
Positron Emission Tomography
Undergo FDG PET CT
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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M.D. Anderson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Nicolas L Palaskas, MD
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Locations
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M D Anderson Cancer Center
Houston, Texas, United States
Countries
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Related Links
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MD Anderson Cancer Center Website
Other Identifiers
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NCI-2021-00838
Identifier Type: REGISTRY
Identifier Source: secondary_id
2020-0206
Identifier Type: OTHER
Identifier Source: secondary_id
2020-0206
Identifier Type: -
Identifier Source: org_study_id
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