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Trial Title:
FDG-PET As an Imaging Modality to Diagnose and Risk Stratify Subclinical, Imaging Negative Ici-Myocarditis
NCT ID:
NCT06566209
Condition:
Subclinical Immune Checkpoint Inhibitor-Induced Myocarditis
Myocarditis
ICI-Myocarditis
Solid Malignant Tumor
Hematologic Malignancy
Subclinical Myocarditis
Subclinical ICI-myocarditis
Conditions: Official terms:
Hematologic Neoplasms
Myocarditis
Fluorodeoxyglucose F18
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Device
Intervention name:
Fluorodeoxyglucose - Positron Emission Tomography (FDG-PET)
Description:
Receive 18F-FDG PET/CT
Arm group label:
Experimental FDG PET/CT
Other name:
18F-fluorodeoxyglucose positron emission tomography
Other name:
Positron Emission Tomography
Other name:
Computed Tomography
Other name:
FDG-PET
Other name:
Positron Emission Tomography-Computed Tomography (PET/CT)
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.
Criteria for eligibility:
Study pop:
Adult male or female patients diagnosed with having a solid tumor or cancers in the blood
and who are undergoing treatment with immune checkpoint inhibitors (ICI) either as a
single agent or in combination with others.
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
- Age ≥18 years at the time of signing informed consent
- Any solid or hematologic malignancy undergoing treatment with ICI (either as a
single agent or in combination with others)
- Ambulatory and able to complete 2-day high fat and low carbohydrate diet with 18
hours fasting (PET diet), 18F-FDG PET/CT scanning, as well as 13N-ammonia PET-CT
myocardial perfusion imaging (part of the routine protocol of the investigation).
These two studies will be done as part of the same imaging set.
- Willing to return to Mayo Clinic for ongoing follow-up
- Elevated troponin T levels (≥100 ng/L)
- Left ventricular ejection fraction (LVEF) ≥50%
- Cardiac MRI (CMR) without evidence of inflammation, coronary assessment available
(either via cardiac computed tomography angiography, CCTA, or via coronary
angiogram) Informed consent obtained before any trial-related activities.
Trial-related activities are any procedures that are carried out as part of the
trial, including activities to determine suitability for the trial.
Exclusion Criteria:
- Chest pain
- Fulminant myocarditis requiring steroid therapy
- Cardiac MRI (CMR) with evidence of inflammation
- On high doses of steroid treatment for other causes
- Clinical presentation consistent with acute coronary syndrome (wall motion
abnormalities consistent with a specific coronary distribution, coronary angiogram
with a culprit lesion identified, patients requiring revascularization either with
percutaneous coronary interventions or coronary artery bypass grafting).
- Patients unable to provide informed consent
- Patients unable to complete the diet preparation protocol
- Pregnancy (all women of child-bearing age and potential will have a negative
pregnancy test within 48 hours of the PET/CT at screen and 6-month visit)
- Breastfeeding
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Mayo Clinic in Rochester
Address:
City:
Rochester
Zip:
55905
Country:
United States
Status:
Recruiting
Contact:
Last name:
Clinical Trials Referral Office
Phone:
855-776-0015
Email:
mayocliniccancerstudies@mayo.edu
Contact backup:
Last name:
Martin G. Rodriguez-Porcel, MD
Start date:
October 11, 2024
Completion date:
April 30, 2027
Lead sponsor:
Agency:
Mayo Clinic
Agency class:
Other
Source:
Mayo Clinic
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06566209
https://www.mayo.edu/research/clinical-trials
