NCT05062395

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 25, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

March 30, 2021

Completed
6 months until next milestone

First Posted

Study publicly available on registry

September 30, 2021

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 4, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 4, 2023

Completed
Last Updated

April 10, 2023

Status Verified

April 1, 2023

Enrollment Period

2 years

First QC Date

February 25, 2021

Last Update Submit

April 7, 2023

Conditions

Myocarditis Acute

Outcome Measures

Primary Outcomes (1)

  • Sensitivity, specificity, positive predictive value, and negative predictive value

    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.

Study Arms (1)

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 TomographyOther: Fludeoxyglucose F-18Other: Low Carbohydrate High Fat DietProcedure: Positron Emission Tomography

Interventions

Computed TomographyPROCEDURE

Undergo FDG PET CT

Also known as: CAT, CAT Scan, Computerized Axial Tomography, Computerized Tomography, CT, CT Scan, tomography
Observational (diet, FDG PET CT)
Fludeoxyglucose F-18OTHER

Undergo FDG PET CT

Also known as: 18FDG, FDG, Fludeoxyglucose (18F), fludeoxyglucose F 18, Fludeoxyglucose F18, Fluorine-18 2-Fluoro-2-deoxy-D-Glucose, Fluorodeoxyglucose F18
Observational (diet, FDG PET CT)
Low Carbohydrate High Fat DietOTHER

low carbohydrate and high fat diet for 48-72 hours

Observational (diet, FDG PET CT)
Positron Emission TomographyPROCEDURE

Undergo FDG PET CT

Also known as: Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron Emission Tomography Scan, Positron-Emission Tomography, proton magnetic resonance spectroscopic imaging
Observational (diet, FDG PET CT)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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

You may not qualify if:

  • Pregnant or lactating patients will be excluded

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

Biospecimen

Retention: SAMPLES WITHOUT DNA

Endomyocardial biopsy specimen

MeSH Terms

Interventions

Fluorodeoxyglucose F18Magnetic Resonance Spectroscopy

Intervention Hierarchy (Ancestors)

DeoxyglucoseDeoxy SugarsCarbohydratesSpectrum AnalysisChemistry Techniques, AnalyticalInvestigative Techniques

Study Officials

  • Nicolas L Palaskas, MD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 25, 2021

First Posted

September 30, 2021

Study Start

March 30, 2021

Primary Completion

April 4, 2023

Study Completion

April 4, 2023

Last Updated

April 10, 2023

Record last verified: 2023-04

Locations

US(1)