PET/MR Imaging for Cardiac Arrhythmias

Overseen By Marc Normandin

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Massachusetts General Hospital

Disqualifiers: Heart disease, Arrhythmia, Diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: Varies per patient

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a new imaging technique, PET-MR, can enhance treatment for individuals with an uneven heartbeat and heart failure. The focus is on improving procedures for those with ventricular arrhythmia, a dangerous heart rhythm issue often found in individuals who have experienced a heart attack. The study will use 18F-TPP, a radiotracer, to compare individuals with this condition to healthy volunteers, assessing whether the imaging can improve treatment success. Individuals with a history of arrhythmia and those planning to undergo a heart procedure called ablation might find this trial relevant. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What prior data suggests that PET-MR imaging is safe for cardiac arrhythmias?

Research has shown that 18F-TPP is an imaging agent under evaluation for safety and effectiveness in treating heart conditions like irregular heartbeats. In studies with patients receiving similar treatments, this imaging method has generally been well-tolerated. Although detailed information on side effects remains limited, ongoing trials suggest the treatment is safe enough to continue testing.

This phase of the trial focuses on further exploring safety. Evidence indicates that the treatment does not cause severe side effects for most people. However, as with any medical treatment, some risks may exist. Participants should discuss these with the study team and their doctors. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the PET/MR imaging trial for cardiac arrhythmias because it offers a novel way to visualize heart conditions. Unlike traditional treatments for arrhythmias, which often rely on medications or invasive procedures, this imaging technique uses the innovative compound 18F-TPP to provide detailed pictures of the heart's electrical activity. This approach can help identify problematic areas more accurately, potentially leading to more effective targeting during procedures like catheter ablation. The hope is that this cutting-edge imaging method will enhance treatment precision and outcomes for patients with recurrent ventricular tachycardia.

What evidence suggests that PET/MR imaging is effective for improving treatment of cardiac arrhythmias?

Research shows that 18F-TPP is a promising tool for improved heart imaging, particularly for patients with conditions like irregular heartbeats. In this trial, participants in the Arrhythmia cohort will undergo imaging with 18F-TPP to assist in procedures such as ablation, where doctors aim to stop abnormal heart rhythms. Studies indicate that 18F-TPP can help doctors understand the heart's electrical system and energy use. Earlier research using PET imaging with 18F-TPP effectively measured certain heart activities, potentially improving treatment success for irregular heartbeats. Although current methods do not cure all patients, this imaging might help doctors more accurately target problem areas, potentially reducing the need for repeat procedures. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

This trial is for adults aged 21-80 with a history of scar-mediated ventricular arrhythmia who are scheduled for ablation therapy. They must be able to consent and have no structural heart disease, MRI/PET contraindications, severe kidney issues, diabetes, lupus, or certain other conditions. Pregnant or lactating women cannot participate.

Inclusion Criteria

I am between 21 and 80 years old.

Subjects must provide informed consent prior to study procedures

I am scheduled for a procedure to treat irregular heartbeats caused by scar tissue.

Exclusion Criteria

I do not have any health conditions or devices that prevent MRI or PET scans.

I have had irregular heartbeats from the lower chambers of my heart.

I have a heart condition like a previous heart attack.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo EAM-guided catheter ablation and PET-MR imaging to assess treatment improvement

Varies per patient

Follow-up

Participants are monitored for safety and effectiveness after ablation treatment

5 years

Repeat Ablation (if necessary)

Participants with recurrent ventricular arrhythmia undergo a second imaging session and repeated ablation

Varies per patient

What Are the Treatments Tested in This Trial?

Interventions

• 18F-TPP

Trial Overview The study tests if PET-MR imaging can help doctors perform ablation more successfully in patients with irregular heart rates due to ventricular arrhythmias. The goal is to improve the procedure's success rate and reduce the need for repeat treatments.

How Is the Trial Designed?

Group I: Treatment Failure Experimental Treatment 1 Intervention

A subset of the Arrhythmia cohort, this group will undergo a second imaging session. This subset corresponds to patients from the Arrhythmia cohort presenting with recurrent ventricular arrhythmia following initial EAM-guided catheter ablation and requiring repeated ablation. It is estimated that 30% of the Arrhythmia cohort patients will require repeat ablation based on rate of repeat ablation procedures at MGH. T

Group II: Arrhythmia Experimental Treatment 1 Intervention

This cohort consist of patients with history of recurrent VT and scheduled for EAM-guided catheter ablation as part of their clinical treatment

Group III: Control Active Control 1 Intervention

Normal subjects without history of cardiac disease or arrhythmia

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

Published Research Related to This Trial

Cardiovascular magnetic resonance (MR) is a safe, non-invasive imaging technique that is the gold standard for assessing heart anatomy and function, but it is important to understand the safety and contraindications of various metal and electronic devices in patients undergoing MR.

The review highlights potential factors affecting image quality and patient comfort, such as arrhythmias and claustrophobia, and discusses the safety and side effects of gadolinium-based contrast agents used in MR imaging.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardiovascular magnetic resonance: What clinicians should know about safety and contraindications. Barison, A., Baritussio, A., Cipriani, A., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10143260/

Stereotactic Arrhythmia Radioablation Treatment of ... Stereotactic arrhythmia radioablation provides an alternative non-invasive and painless therapeutic strategy for the treatment of previously detected cardiac ...

2. jnm.snmjournals.org jnm.snmjournals.org/content/62/11/1591

Metabolic Scar Assessment with18F-FDG PET: Correlation to ... Catheter ablation for ventricular tachycardia (VT) is an effective treatment option for patients with ischemic heart disease and drug-refractory ...

3. jacc.org jacc.org/doi/full/10.1016/j.jcmg.2011.11.017

4-[18F]-Tetraphenylphosphonium as a PET Tracer for Myocardial ... We tested the hypothesis that quantitative PET imaging of 18F-TPP is useful for in vivo measurement of myocardial ΔΨm. Although data on in vivo measurement of ...

4. pubs.rsna.org pubs.rsna.org/doi/full/10.1148/radiol.221052

Myocardial Activity at 18 F-FAPI PET/CT and Risk for ... FAPI PET/CT imaging indicated intense and heterogeneous activity in hypertrophic cardiomyopathy, and FAPI uptake was associated with 5-year risk of sudden ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11753837/

Stereotactic arrhythmia radioablation for ventricular ... Stereotactic management of arrhythmia - radiosurgery in treatment of ventricular tachycardia (SMART-VT). Results of a prospective safety trial.

6. ahajournals.org ahajournals.org/doi/10.1161/CIRCRESAHA.122.319835

Arrhythmias as Presentation of Genetic Cardiomyopathy Genetic cardiomyopathy should be considered in patients who present with arrhythmias assumed to be idiopathic, including atrial fibrillation, ...

7. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1002/joa3.12276

Ventricular Tachycardia - 2019 - Journal of Arrhythmia Trans-catheter radio frequency ablation (RFA) of outflow tract ventricular tachycardia has a decent success rate of up to 82%. But the recurrences are possible ...

8. journals.lww.com journals.lww.com/10.2459/JCM.0000000000001121

Role of cardiac imaging in patients undergoing catheter... Ventricular tachycardia is a major health issue in patients with structural heart disease (SHD). Implantable cardioverter defibrillator (ICD) therapy has ...