Imaging and Treatment Planning for Cardiac Radioablation
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorStewart Gaede
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Ischemic cardiomyopathy with monomorphic VT
Referred by cardiologists
18 years of age or older
Disqualifiers
• 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
Trial design
Design model
Single group
Treatments tested in this trial
CT and MRI
Diagnostic testAll 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.
Treatment groups
15 Participants
are divided into 1 treatment groupGroup A: CT and MRIExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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..
Time frame
6 months after conclusion of study2
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.
Time frame
6 months after conclusion of studySecondary outcomes
1
Agreement between CT/MRI areas of interest (scar), assessed using similarity metrics such as the Dice coefficient and Hausdorff distance.
Time frame
6 months after conclusion of studySponsors and contacts
Click on the lead sponsor to view all of their trials.
Stewart Gaede
Lead sponsor
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor institution
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: