search
Back to results

Evaluation of PET/MR in Patients Selected for Ablation Therapy

Primary Purpose

Arrhythmias, Cardiac

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
18F-TPP
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Arrhythmias, Cardiac

Eligibility Criteria

21 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Healthy Volunteers

Inclusion Criteria:

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

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:

Inclusion criteria

  • 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

  • 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;

Sites / Locations

  • Massachusetts General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Control

Arrhythmia

Treatment Failure

Arm Description

Normal subjects without history of cardiac disease or arrhythmia

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

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

Outcomes

Primary Outcome Measures

TPP imaging in Ventricular Arrhythmia
Establish imaging patterns allowing prediction of VT ablation failure

Secondary Outcome Measures

Full Information

First Posted
August 25, 2017
Last Updated
July 2, 2023
Sponsor
Massachusetts General Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT03265431
Brief Title
Evaluation of PET/MR in Patients Selected for Ablation Therapy
Official Title
Evaluation of PET/MR in Patients Selected for Ablation Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 14, 2017 (Actual)
Primary Completion Date
June 30, 2027 (Anticipated)
Study Completion Date
June 30, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arrhythmias, Cardiac

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Active Comparator
Arm Description
Normal subjects without history of cardiac disease or arrhythmia
Arm Title
Arrhythmia
Arm Type
Experimental
Arm Description
This cohort consist of patients with history of recurrent VT and scheduled for EAM-guided catheter ablation as part of their clinical treatment
Arm Title
Treatment Failure
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
18F-TPP
Other Intervention Name(s)
18F-BFPET
Intervention Description
Imaging with 18-F-TPP (18F-BFPET)
Primary Outcome Measure Information:
Title
TPP imaging in Ventricular Arrhythmia
Description
Establish imaging patterns allowing prediction of VT ablation failure
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Healthy Volunteers Inclusion Criteria: Subjects must be ≥21 and ≤80 years of age; Subjects must provide informed consent prior to study procedures; 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: Inclusion criteria 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 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;
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marina Macdonald-Soccorso, BS
Phone
617-643-1967
Email
MMACDONALD-SOCCORSO@mgh.harvard.edu

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32719915
Citation
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.
Results Reference
derived

Learn more about this trial

Evaluation of PET/MR in Patients Selected for Ablation Therapy

We'll reach out to this number within 24 hrs