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NCT05062395 · ClinicalTrials.gov registry record
Positron Emission Tomography for the Diagnosis of Immune Checkpoint Inhibitor-Related Myocarditis
A clinical trial, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- 13
- Enrollment target
NCT05062395: Completed study, sponsored by M.D. Anderson Cancer Center.
NCT05062395 is a clinical trial that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 13 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05062395 has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- 13 participants
- Enrollment target
Study 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.
Primary Outcome
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) cur
Interventions
- PROCEDURE Computed Tomography
- PROCEDURE Positron Emission Tomography
- OTHER Fludeoxyglucose F-18
- OTHER Low Carbohydrate High Fat Diet
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2021-03-30 |
| Est. Completion | 2023-04-04 |
What the finished NCT05062395 record still lists
NCT05062395 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 13 participants, a relatively small participant target.
The record links to 0 conditions, and to 4 interventions - of which Computed Tomography is the first listed.
NCT05062395 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05062395 about?
NCT05062395 is a clinical study titled "Positron Emission Tomography for the Diagnosis of Immune Checkpoint Inhibitor-Related Myocarditis". 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 th...
What is the current status of trial NCT05062395?
This trial is currently completed. The enrollment target is 13 participants. The study started on 2021-03-30. Estimated completion is 2023-04-04.
What interventions are being tested in trial NCT05062395?
The interventions under investigation include: Computed Tomography (PROCEDURE), Positron Emission Tomography (PROCEDURE), Fludeoxyglucose F-18 (OTHER), Low Carbohydrate High Fat Diet (OTHER).
Who is sponsoring clinical trial NCT05062395?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
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