Subclinical Immune Checkpoint Inhibitor-Induced MyocarditisNCT06566209
FDG-PET as an Imaging Modality to Diagnose and Risk Stratify Subclinical, Imaging Negative Ici-Myocarditis
An observational study of Subclinical Immune Checkpoint Inhibitor-Induced Myocarditis and Myocarditis, run by Mayo Clinic at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Subclinical Immune Checkpoint Inhibitor-Induced Myocarditis, Myocarditis, ICI-Myocarditis
- What is being tested?
- Fluorodeoxyglucose - Positron Emission Tomography (FDG-PET)
- Type of treatment
- Medical device
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Oct 2024to 22 Dec 2025
- 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: 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.
Who may be able to join
- 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 a 48-72 hour 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
- Left ventricular ejection fraction (LVEF) ≥45%
- Cardiac MRI (CMR) without conclusive 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.
Who cannot join
- Fulminant myocarditis requiring steroid therapy
- CMR with definitive evidence of myocarditis
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: 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
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
- Being tested
- Fluorodeoxyglucose - Positron Emission Tomography (FDG-PET)
- Medical subject headings
- Myocarditis, Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluorodeoxyglucose - Positron Emission Tomography (FDG-PET)Device
Also called 18F-fluorodeoxyglucose positron emission tomography, Positron Emission Tomography, Computed Tomography, FDG-PET
Receive 18F-FDG PET/CT
| Study group | Role | What they receive |
|---|---|---|
| Experimental FDG PET/CT | Patients undergo 18F-FDG and 13N-ammonia PET/CT scan, blood sample collection and have their medical records reviewed on study. Receives: Device: Fluorodeoxyglucose - Positron Emission Tomography (FDG-PET) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presennce of inflammation or scarring
Assessed by reviewing 18F-FDG PET/CT imaging for presence of inflammation, progression/regression of inflammation or scarring.
Measured: Baseline; Up to 7 months
Secondary outcomes (3)
Incidence of hospitalization
Assessed by review of medical record for incidence of hospitalization
Measured: Up to 2 years
Cardiovascular Intensive Care Unit (CICU) Level of Care Days
Assessed by reviewing medical record for number of days, if any, of CICU care.
Measured: Up to 2 years
Incidence of arrhythmias
Assessed by reviewing medical record for incidence of cardiac arrhythmias.
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2024
- Study start11 Oct 2024
- Primary completion22 Dec 2025
- Study completion22 Dec 2025
Why it stopped: Low/slow accrual (change in standard treatment practice)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subclinical Immune Checkpoint Inhibitor-Induced MyocarditisStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Martin G. Rodriguez-Porcel, MD, Principal investigator, Mayo Clinic in Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06566209
- Sponsor's protocol ID
- 24-001222
- Status last verified
- May 2026
- First submitted
- 20 Aug 2024
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06566209
- Acronym / sponsor ID
- 24-001222
- Conditions
- Subclinical Immune Checkpoint Inhibitor-Induced Myocarditis, Myocarditis, ICI-Myocarditis, Solid Malignant Tumor, Hematologic Malignancy, Subclinical Myocarditis
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Low/slow accrual (change in standard treatment practice)
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 11 Oct 2024 (actual)
- Primary completion
- 22 Dec 2025 (actual)
- Study completion
- 22 Dec 2025 (actual)
- First posted
- 22 Aug 2024 (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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental FDG PET/CT | – | Device: Fluorodeoxyglucose - Positron Emission Tomography (FDG-PET)Patients undergo 18F-FDG and 13N-ammonia PET/CT scan, blood sample collection and have their medical records reviewed on study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (6 listed)
- 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 a 48-72 hour 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
- Left ventricular ejection fraction (LVEF) ≥45%
Key exclusion criteria (7 listed)
- Fulminant myocarditis requiring steroid therapy
- CMR with definitive evidence of myocarditis
- 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
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 |
|---|---|---|
| Fluorodeoxyglucose - Positron Emission Tomography (FDG-PET)Also: 18F-fluorodeoxyglucose positron emission tomography, Positron Emission Tomography, Computed Tomography, FDG-PETReceive 18F-FDG PET/CT | Device | Experimental FDG PET/CT |
Primary outcome
Presennce of inflammation or scarring
Time frame: Baseline; Up to 7 months
Assessed by reviewing 18F-FDG PET/CT imaging for presence of inflammation, progression/regression of inflammation or scarring.
3 secondary outcomes
Incidence of hospitalization
Time frame: Up to 2 years
Cardiovascular Intensive Care Unit (CICU) Level of Care Days
Time frame: Up to 2 years
Incidence of arrhythmias
Time frame: Up to 2 years
Results and safety
The study was stopped early (reason given: Low/slow accrual (change in standard treatment practice)). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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.
Martin G. Rodriguez-Porcel, MD principal investigator
Mayo Clinic in Rochester
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 Subclinical Immune Checkpoint Inhibitor-Induced Myocarditis and Myocarditis, run by Mayo Clinic 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 6 inclusion and 7 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: stopped early, as of the sponsor's last update on 8 May 2026. 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 was stopped early (reason given: Low/slow accrual (change in standard treatment practice)). Results are not available in the source record.
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?
Presennce of inflammation or scarring (time frame: Baseline; Up to 7 months). 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 8 May 2026.