Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT05062395 |
Other study ID # |
2020-0206 |
Secondary ID |
NCI-2021-0083820 |
Status |
Completed |
Phase |
|
First received |
|
Last updated |
|
Start date |
March 30, 2021 |
Est. completion date |
April 4, 2023 |
Study information
Verified date |
April 2023 |
Source |
M.D. Anderson Cancer Center |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical Trial 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.
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.