Trials / Recruiting
RecruitingNCT06566209
FDG-PET as an Imaging Modality to Diagnose and Risk Stratify Subclinical, Imaging Negative Ici-Myocarditis
Positron Emission Tomography for the Detection of Subclinical Immune Checkpoint Inhibitor-Induced Myocarditis (PET-SIM): A Prospective, Single Center, Single Arm, Open Label Pilot Study
- Status
- Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 30 (estimated)
- Sponsor
- Mayo Clinic · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this pilot study is to evaluate Fluorodeoxyglucose - Positron Emission Tomography (FDG-PET) as an imaging modality to diagnose and risk stratify subclinical, imaging negative ICI-myocarditis, and to determine whether subclinical ICI-induced myocarditis is a distinct and clinically relevant entity with a risk of progression to fulminant myocarditis.
Conditions
- Subclinical Immune Checkpoint Inhibitor-Induced Myocarditis
- Myocarditis
- ICI-Myocarditis
- Solid Malignant Tumor
- Hematologic Malignancy
- Subclinical Myocarditis
- Subclinical ICI-myocarditis
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Fluorodeoxyglucose - Positron Emission Tomography (FDG-PET) | Receive 18F-FDG PET/CT |
Timeline
- Start date
- 2024-10-11
- Primary completion
- 2027-04-30
- Completion
- 2027-04-30
- First posted
- 2024-08-22
- Last updated
- 2025-10-15
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT06566209. Inclusion in this directory is not an endorsement.