Myocarditis AcuteNCT05062395
Positron Emission Tomography for the Diagnosis of Immune Checkpoint Inhibitor-Related Myocarditis
An observational study of Myocarditis Acute, run by M.D. Anderson Cancer Center at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocarditis Acute
- What is being tested?
- Computed Tomography, Fludeoxyglucose F-18 and Low Carbohydrate High Fat Diet
- Type of treatment
- Surgery or procedure
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Mar 2021to 4 Apr 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients being treated with ICI and presenting to the University of Texas MD Anderson Cancer Center (MDACC) with suspected ICI-related myocarditis
Who may be able to join
- 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
Who cannot join
- Pregnant or lactating patients will be excluded
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
PRIMARY OBJECTIVE:
- 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:
- 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.
- 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
- Myocarditis Acute
- Being tested
- Computed Tomography, Fludeoxyglucose F-18, Low Carbohydrate High Fat Diet, Positron Emission Tomography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computed TomographyProcedure or surgery
Also called CAT, CAT Scan, Computerized Axial Tomography, Computerized Tomography
Undergo FDG PET CT
Fludeoxyglucose F-18Other
Also called 18FDG, FDG, Fludeoxyglucose (18F), fludeoxyglucose F 18
Undergo FDG PET CT
Low Carbohydrate High Fat DietOther
low carbohydrate and high fat diet for 48-72 hours
Positron Emission TomographyProcedure or surgery
Also called Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron Emission Tomography Scan
Undergo FDG PET CT
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Computed Tomography; Other: Fludeoxyglucose F-18; Other: Low Carbohydrate High Fat Diet; Procedure: Positron Emission Tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: through study completion, an average of a year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2021
- Study start30 Mar 2021
- Primary completion4 Apr 2023
- Study completion4 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocarditis AcuteStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicolas L Palaskas, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05062395
- Sponsor's protocol ID
- 2020-0206
- Other IDs
- NCI-2021-00838, 2020-0206
- Status last verified
- Apr 2023
- First submitted
- 25 Feb 2021
- Last updated
- 10 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Positron Emission Tomography for the Diagnosis of Immune Checkpoint Inhibitor-Related Myocarditis
- ClinicalTrials.gov ID
- NCT05062395
- Acronym / sponsor ID
- 2020-0206
- Conditions
- Myocarditis Acute
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 30 Mar 2021 (actual)
- Primary completion
- 4 Apr 2023 (actual)
- Study completion
- 4 Apr 2023 (actual)
- First posted
- 30 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVE:
- 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:
- 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.
- 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational (diet, FDG PET CT) | – | Procedure: Computed Tomography, Other: Fludeoxyglucose F-18, Other: Low Carbohydrate High Fat Diet, Procedure: Positron Emission TomographyPatients receive a low carbohydrate and high fat diet for 48-72 hours. Patients receive FDG then undergo PET CT. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients being treated with ICI and presenting to the University of Texas MD Anderson Cancer Center (MDACC) with suspected ICI-related myocarditis
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Pregnant or lactating patients will be excluded
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Computed TomographyAlso: CAT, CAT Scan, Computerized Axial Tomography, Computerized TomographyUndergo FDG PET CT | Procedure or surgery | Observational (diet, FDG PET CT) |
| Fludeoxyglucose F-18Also: 18FDG, FDG, Fludeoxyglucose (18F), fludeoxyglucose F 18Undergo FDG PET CT | Other | Observational (diet, FDG PET CT) |
| Low Carbohydrate High Fat Dietlow carbohydrate and high fat diet for 48-72 hours | Other | Observational (diet, FDG PET CT) |
| Positron Emission TomographyAlso: Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron Emission Tomography ScanUndergo FDG PET CT | Procedure or surgery | Observational (diet, FDG PET CT) |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2023.
- MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicolas L Palaskas, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myocarditis Acute, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity, specificity, positive predictive value, and negative predictive value (time frame: through study completion, an average of a year.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2023.