Imaging and Treatment Planning for Cardiac Radioablation

NCT06938074 | Not Yet Recruiting

• 1 other identifier: 126882
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

Cardiac radioablation is a new treatment for ventricular tachycardia (VT), which uses beams of radiation to treat heart scar that causes VT. To identify the scar areas, magnetic resonance imaging (MRI) and computed tomography (CT) imaging are often used. These are both types of medical imaging that allow clinicians to examine scar area without having to do invasive surgery. Researchers have developed new heart imaging protocols using both MRI and CT. Their MRI protocol method can now spot both dense and scattered scar tissue. The CT protocol combines multiple different types of scans into a single appointment and uses a special scanner that captures the motion of the heart. For this study, patients will undergo CT and MRI imaging according to these new imaging protocols. With this study, researchers aim to show that these new imaging protocols can be undergone by patients with ventricular tachycardia and can be used to identify scar. Researchers will also use these scans to make radiation treatment plans to identify which types of treatment can be delivered safely to patients.

Conditions

Ventricular Tachycardia, Monomorphic; Ventricular Tachycardia (V-Tach); Ischemia, Myocardial

Keywords

Cardiac radioablation; Stereotactic arrhythmia radioablation; Ischemic fibrosis; Late iodine enhancement CT; CT perfusion; Late gadolinium enhanced MRI

Outcome Measures

Primary Outcomes (2)

• Agreement among cardiologists for target regions, assessed by an inter- and intra-observer variability study using similarity metrics such as the Dice coefficient and Hausdorff distance.

  Imaging protocols will be delivered to participants. Targets will be delineated by experts. Agreement between experts will be assessed..

  6 months after conclusion of study

• Adherence of treatment plans to dose constraints and deliverability of treatment plans.

  Treatment plans will be created using various motion management and radiation treatment delivery strategies. Adherence of treatment plans to dose constraints will be assessed by comparing treatment plans to institutional dose constraints. Beam deliverability will be assessed by delivering the treatment plan to a static phantom and comparing the deposited dose to the expected dose. Treatment deliverability, as it relates to motion management, will be assessed by delivering the treatment plan to a moving phantom and comparing the deposited dose to the expected dose.

  6 months after conclusion of study

Secondary Outcomes (1)

• Agreement between CT/MRI areas of interest (scar), assessed using similarity metrics such as the Dice coefficient and Hausdorff distance.

  6 months after conclusion of study

Study Arms (1)

CT and MRI

EXPERIMENTAL

All participants will undergo both CT imaging and MRI imaging to identify areas of ischemic scar. Treatment plans will be created based on CT scans, using various treatment delivery and motion management techniques.

Diagnostic Test: CT and MRI

Interventions

CT and MRI DIAGNOSTIC_TEST

All participants will undergo both CT imaging and MRI imaging to identify areas of ischemic scar. Treatment plans will be created based on CT scans, for all participants using various treatment delivery and motion management techniques.

CT and MRI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ischemic cardiomyopathy with monomorphic VT
• Referred by cardiologists

You may not qualify if:

• Polymorphic ventricular tachycardia
• Ventricular fibrillation
• Pregnant or breastfeeding or planning to become pregnant or breastfeed during the study
• Estimated glomerular filtration rate ≤ 30 mL/min/1.73m2
• Previous allergic reaction to CT contrast agent Note that participants with contraindications for MRI can still be enrolled in this study but will not undergo MRI parts of this protocol.

Sponsors & Collaborators

• Stewart Gaede: lead

Study Sites (1)

London Health Sciences Centre Research Inc

London, Ontario, Canada

Location

MeSH Terms

Conditions

Tachycardia, Ventricular; Myocardial Ischemia

Interventions

Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Tachycardia; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Vascular Diseases

Intervention Hierarchy (Ancestors)

Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Central Study Contacts

Stewart Gaede, PhD

CONTACT

519-685-8600; stewart.gaede@lhsc.on.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief Medical Physicist

Study Record Dates

• First Submitted: April 7, 2025
• First Posted: April 22, 2025
• Study Start: November 1, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: September 26, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)