Evaluation of PET/MR in Patients Selected for Ablation Therapy

NCT ID: NCT03265431

Last Updated: 2024-01-30

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-07-14
• Study Completion Date: 2027-06-30

Brief Summary

This study is performed to assess if PET-MR imaging can improve treatment of patients with irregular heart rate and heart failure. Heart failure occurs when the heart muscle is too weak to do his work correctly. Irregular heart rate can be related to numerous diseases. One category of irregular heart rate is called ventricular arrhythmia. It is often seen in patients who have had a heart attack. This type of arrhythmia can be dangerous and can cause sudden death. To prevent these arrhythmias, doctors can perform procedures that burn the source of arrhythmia in the heart muscle. This is called ablation. Unfortunately, ablation does not fix the problem in 100% of patients and some will still have the arrhythmia requiring repeated procedure. The purpose of this study is to find new ways of guiding the doctors performing ablation, hoping to improve the success rate of the procedure.

Conditions

Arrhythmias, Cardiac

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Control

Normal subjects without history of cardiac disease or arrhythmia

Group Type: ACTIVE_COMPARATOR

18F-TPP

Intervention Type: DRUG

Imaging with 18-F-TPP (18F-BFPET)

Arrhythmia

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

Group Type: EXPERIMENTAL

18F-TPP

Intervention Type: DRUG

Imaging with 18-F-TPP (18F-BFPET)

Treatment Failure

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 Type: EXPERIMENTAL

18F-TPP

Intervention Type: DRUG

Imaging with 18-F-TPP (18F-BFPET)

Interventions

18F-TPP

Imaging with 18-F-TPP (18F-BFPET)

Intervention Type: DRUG

Other Intervention Names

18F-BFPET

Eligibility Criteria

Inclusion Criteria

• Subjects must be ≥21 and ≤80 years of age;
• Subjects must provide informed consent prior to study procedures;

• Subjects must be ≥21 and ≤80 years of age;
• Subjects must provide informed consent prior to study procedures;
• History of scar-mediated ventricular arrhythmia scheduled for invasive EAM-guided catheter ablation for clinical care

Exclusion Criteria

• Known structural heart disease (e.g. myocardial infarction);
• History of ventricular arrhythmia;
• Any contraindication to MRI and/or PET, including:
• Subjects with life vest;
• Subjects with implanted heart device (e.g. ICD, Pacemaker);
• Subjects with metallic fragment or foreign body;
• Subjects with other form of devices or prosthesis that are not MRI compatible, such as insulin pump, joint replacement, hearing aid, cochlear implant, permanent contraceptive devices, etc.;
• Claustrophobia;
• Relative or absolute contraindication to Dotarem contrast:
• history of renal disease including acute or chronic severe renal insufficiency (glomerular filtration rate <60 mL/min/1.73m2);
• a history of diabetes mellitus, systemic lupus, multiple myeloma, nephrogenic systemic fibrosis, and other co-morbidities;
• History of hypersensitive reactions to Dotarem and/or gadolinium contrast agent
• Any clinically significant acute or unstable physical or psychological disease, judged by the investigators based on medical history or screening physical examination, to be incompatible with the study;
• Any physical or psychological disease judged by the investigators to be incompatible with the study, based on medical history or screening physical examination
• Radiation exposure exceeds current Radiology Department guidelines (i.e. 50 mSv in the prior 12 months);
• Female subjects only: Positive serum and/or urine pregnancy test, or lactating, or possibility of pregnancy cannot be ruled out prior to dosing;
• Inability to provide written informed consent;

Arrhythmia Subjects:

• Any contraindication to MRI and/or PET, including:
• Subjects with life vest;
• Subjects with implanted heart device (e.g. ICD, Pacemaker);
• Subjects with metallic fragment or foreign body;
• Subjects with other form of devices or prosthesis that are not MRI compatible, such as insulin pump, joint replacement, hearing aid, cochlear implant, permanent contraceptive devices, etc.;
• Claustrophobia;
• Relative or absolute contraindication to Dotarem contrast:
• history of renal disease including acute or chronic severe renal insufficiency (glomerular filtration rate <60 mL/min/1.73m2);
• history of diabetes mellitus, systemic lupus, multiple myeloma, nephrogenic systemic fibrosis, and other co-morbidities;
• History of hypersensitive reactions to Dotarem and/or gadolinium contrast agent;Any clinically significant acute or unstable physical or psychological disease, judged by the investigators based on medical history or screening physical examination, to be incompatible with the study;
• Any physical or psychological disease judged by the investigators to be incompatible with the study, based on medical history or screening physical examination
• Radiation exposure exceeds current Radiology Department guidelines (i.e. 50 mSv in the prior 12 months);
• Female subjects only: Positive serum and/or urine pregnancy test, or lactating, or possibility of pregnancy cannot be ruled out prior to dosing;
• Inability to provide written informed consent;

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Marc D.Normandin, Ph.D

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Countries

United States

References

Pelletier-Galarneau M, Petibon Y, Ma C, Han P, Kim SJW, Detmer FJ, Yokell D, Guehl N, Normandin M, El Fakhri G, Alpert NM. In vivo quantitative mapping of human mitochondrial cardiac membrane potential: a feasibility study. Eur J Nucl Med Mol Imaging. 2021 Feb;48(2):414-420. doi: 10.1007/s00259-020-04878-9. Epub 2020 Jul 27.

Reference Type: DERIVED

PMID: 32719915 (View on PubMed)

Other Identifiers

2016P002123

Identifier Type: -

Identifier Source: org_study_id