Clinical trial NCT06938074: Imaging and Treatment Planning for Cardiac Radioablation
Official title: Imaging and Treatment Planning for Cardiac Radioablation
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Ventricular Tachycardia, Monomorphic
Ventricular Tachycardia (V-Tach)
Ventricular Tachycardia (VT)
Keywords: Cardiac radioablation
Stereotactic arrhythmia radioablation
Ischemic fibrosis
Late iodine enhancement CT
CT perfusion
Late gadolinium enhanced MRI
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
Collaborators: name: Western University, Canada
name: London Health Science Centre
name: St. Joseph's Health Care London
First posted: 2025-04-22
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to (1) determine whether computed tomography (CT) imaging can be used to identify areas of ischemic scar, which are often used as radiation targets for cardiac radioablation, just as well as MRI can, and (2) to determine how best to deliver cardiac radioablation treatment to a patient, for example, which treatment machine should be used and how to limit the effect of chest movement during treatment.

Participants will undergo two separate imaging appointments: one CT imaging appointment, where they will undergo scans including perfusion scans, late enhancement scans, and radiation therapy treatment planning scans; and one MRI appointment, where they will undergo scans including a late enhancement scan. The overlap in areas of ischemic scar as identified in CT scans and MRI scans will be quantified.

Using radiation therapy treatment planning CT scans, the safety and feasibility of different treatment and motion management techniques will be evaluated. Treatment plans will be created using these different techniques and will be compared to one another. These plans will also be evaluated for compliance with dose constraints.


Eligibility criteria: Inclusion Criteria

* Ischemic cardiomyopathy with monomorphic VT
* Referred by cardiologists
* 18 years of age or older Exclusion Criteria
* 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
* Unable to undergo MRI due to metal implants
* Previous allergic reaction to CT contrast agent

Primary outcomes:
measure: Similarity and overlap of areas of ischemic scar defined in CT and MRI as evaluated by similarity metrics (Dice Similarity Coefficient, Hausdorff Distance)
timeFrame: 6 months after conclusion of study
measure: Safety and deliverability of cardiac radioablation treatments, as evaluated by adherence to institutional dose-volume histogram constraints (safety) and accurate delivery to a phantom (deliverability)
timeFrame: 6 months after conclusion of study
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: Canada
facility: London Health Sciences Centre Research Inc
state: Ontario
Study officials:
References: