search
Back to results

Imaging With a Radio Tracer to Guide VT Ablations

Primary Purpose

Ventricular Tachycardia, Arrhythmia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
123I-metaiodobenzylguanidine
Sponsored by
University of Maryland, Baltimore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ventricular Tachycardia focused on measuring Ablation, Arrythmia, Imaging

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with ventricular arrhythmias requiring VT Ablation
  • Patients must be 18 years of age or older
  • Patient must be able to sign consent form
  • Patient must be willing to come back for the 6 month visit for additional study procedures

Exclusion Criteria:

  • Patient under 18 years old
  • Inability to sign consent
  • Pregnant Women

Sites / Locations

  • University of Maryland Medical Center, EP Lab, Rm. N3W77

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Imaging Tracer

Arm Description

No arms, the Radio tracer will be used in all subjects imaging tests.

Outcomes

Primary Outcome Measures

Comparison of the Percentage of Patients With Scar in Each Segment as Determined by MIBG SPECT Versus Electroanatomic at Baseline
Scar Measurement on both MIBG 3D map and electroanatomic scare defined as bipolar voltage <0.5mV using Standard 17-segment American Heart Association areas.

Secondary Outcome Measures

Median Segmental MIBG Uptake at Baseline
The median uptake of the standard 17 heart segments was determined at baseline
Median Segmental MIBG Uptake at 6 Months After Ablation
MIBG/SPECT imaging 6 months after ablation. 123I-metaiodobenzylguanidine: For the imaging study, an activity of 370 MBq (10 mCi) 123I-mIBG (GE Healthcare) was administered intravenously, and a 10-minute planar image of the anterior thorax (128_128 matrix) was acquired beginning 15 minutes after tracer injection.

Full Information

First Posted
July 28, 2010
Last Updated
January 25, 2022
Sponsor
University of Maryland, Baltimore
Collaborators
GE Healthcare
search

1. Study Identification

Unique Protocol Identification Number
NCT01250912
Brief Title
Imaging With a Radio Tracer to Guide VT Ablations
Official Title
Three Dimension Neuron Imaging Using 123I-metaiodobenzylguanidine Single Photon Emission Computed Tomography to Guide Ventricular Tachycardia Ablations
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
July 1, 2019 (Actual)
Study Completion Date
July 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Maryland, Baltimore
Collaborators
GE Healthcare

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Some patients are at risk for life-threatening fast heart rates. These can frequently be treated by using a catheter inside the heart to burn away the cells that create the fast heart rates. The purpose of this study is to image the nerves inside the heart of those patients. The investigators want to find out if abnormalities in the nervous system in the heart can help the physician to find the area that needs to be burnt away.
Detailed Description
Ventricular tachycardia is the next frontier in cardiology. Patients that have scar in the heart (for example after heart attacks) are at an increased risk of developing ventricular tachycardia. In these patients ventricular tachycardia represents an electrical wave front that circulates in the heart muscle using the scar in the heart. An increasing number of patients with ventricular tachycardia require cauterization (burning away) of the tissue to treat this life-threatening condition. The goal of this cauterization or ablation is to destroy "highways of surviving tissue" inside the scar, that allow ventricular tachycardia to exist. However, this can be very lengthy procedure (>5 hours) that has only a moderate success in the long run. Therefore, new treatment approaches are needed to make this procedure better. The purpose of this study is to assess if radio tracers showing the nerve distribution in the heart (cardiac innervation) can be used in addition to the current technology ("voltage mapping") to identify the area that needs to be ablated (burnt away) to treat life-threatening fast heart rates (ventricular tachycardia) Certain patterns of nerve distribution in the heart (sympathetic cardiac innervation) have been shown to predict outcome for different heart diseases, like heart transplant, coronary artery disease, heart failure, arrhythmias. One substance that allows visualization of the cardiac innervation is 123I-metaiodobenzylguanidine (123I-MIBG), which could provide additional information to understand and treat ventricular tachycardia.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ventricular Tachycardia, Arrhythmia
Keywords
Ablation, Arrythmia, Imaging

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Imaging Tracer
Arm Type
Experimental
Arm Description
No arms, the Radio tracer will be used in all subjects imaging tests.
Intervention Type
Drug
Intervention Name(s)
123I-metaiodobenzylguanidine
Other Intervention Name(s)
MIGB
Intervention Description
FDA Approved for use in Cancer patients. This use is Off Label. For the imaging study, an activity of 370 MBq (10 mCi) 123I-mIBG (GE Healthcare) will be administered intravenously, and a 10-minute planar image of the anterior thorax (128_128 matrix) will be acquired beginning 15 minutes after tracer injection.
Primary Outcome Measure Information:
Title
Comparison of the Percentage of Patients With Scar in Each Segment as Determined by MIBG SPECT Versus Electroanatomic at Baseline
Description
Scar Measurement on both MIBG 3D map and electroanatomic scare defined as bipolar voltage <0.5mV using Standard 17-segment American Heart Association areas.
Time Frame
Baseline
Secondary Outcome Measure Information:
Title
Median Segmental MIBG Uptake at Baseline
Description
The median uptake of the standard 17 heart segments was determined at baseline
Time Frame
Baseline
Title
Median Segmental MIBG Uptake at 6 Months After Ablation
Description
MIBG/SPECT imaging 6 months after ablation. 123I-metaiodobenzylguanidine: For the imaging study, an activity of 370 MBq (10 mCi) 123I-mIBG (GE Healthcare) was administered intravenously, and a 10-minute planar image of the anterior thorax (128_128 matrix) was acquired beginning 15 minutes after tracer injection.
Time Frame
6 months after ablation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with ventricular arrhythmias requiring VT Ablation Patients must be 18 years of age or older Patient must be able to sign consent form Patient must be willing to come back for the 6 month visit for additional study procedures Exclusion Criteria: Patient under 18 years old Inability to sign consent Pregnant Women
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Timm R Dickfeld, MD,Ph.D
Organizational Affiliation
University of Maryland Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Maryland Medical Center, EP Lab, Rm. N3W77
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
19467512
Citation
Tian J, Smith MF, Jeudy J, Dickfeld T. Multimodality fusion imaging using delayed-enhanced cardiac magnetic resonance imaging, computed tomography, positron emission tomography, and real-time intracardiac echocardiography to guide ventricular tachycardia ablation in implantable cardioverter-defibrillator patients. Heart Rhythm. 2009 Jun;6(6):825-8. doi: 10.1016/j.hrthm.2009.02.032. Epub 2009 Feb 24. No abstract available.
Results Reference
background
PubMed Identifier
19207761
Citation
Tian J, Smith MF, Chinnadurai P, Dilsizian V, Turgeman A, Abbo A, Gajera K, Xu C, Plotnick D, Peters R, Saba M, Shorofsky S, Dickfeld T. Clinical application of PET/CT fusion imaging for three-dimensional myocardial scar and left ventricular anatomy during ventricular tachycardia ablation. J Cardiovasc Electrophysiol. 2009 Jun;20(6):567-604. doi: 10.1111/j.1540-8167.2008.01377.x.
Results Reference
background
PubMed Identifier
18417016
Citation
Dickfeld T, Kocher C. The role of integrated PET-CT scar maps for guiding ventricular tachycardia ablations. Curr Cardiol Rep. 2008 Mar;10(2):149-57. doi: 10.1007/s11886-008-0025-1.
Results Reference
background
PubMed Identifier
25713216
Citation
Klein T, Abdulghani M, Smith M, Huang R, Asoglu R, Remo BF, Turgeman A, Mesubi O, Sidhu S, Synowski S, Saliaris A, See V, Shorofsky S, Chen W, Dilsizian V, Dickfeld T. Three-dimensional 123I-meta-iodobenzylguanidine cardiac innervation maps to assess substrate and successful ablation sites for ventricular tachycardia: feasibility study for a novel paradigm of innervation imaging. Circ Arrhythm Electrophysiol. 2015 Jun;8(3):583-91. doi: 10.1161/CIRCEP.114.002105. Epub 2015 Feb 23.
Results Reference
result

Learn more about this trial

Imaging With a Radio Tracer to Guide VT Ablations

We'll reach out to this number within 24 hrs