Ventricular Tachycardia, MonomorphicITPCRNCT06938074
Imaging and Treatment Planning for Cardiac Radioablation
A study testing CT and MRI in people with Ventricular Tachycardia, Monomorphic and Ventricular Tachycardia (V-Tach), run by Stewart Gaede at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventricular Tachycardia, Monomorphic, Ventricular Tachycardia (V-Tach), Ischemia, Myocardial
- What is being tested?
- CT and MRI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteCanada
- Study dates
- 1 Nov 2025to 1 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site
London Health Sciences Centre Research Inc
London, Ontario
Stewart Gaede, PhD, 5196858600 ext. 53144, stewart.gaede@lhsc.on.ca
About this study
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
- Being tested
- CT and MRI
- Keywords
- Cardiac radioablation, Stereotactic arrhythmia radioablation, Ischemic fibrosis, Late iodine enhancement CT, CT perfusion, Late gadolinium enhanced MRI
- Medical subject headings
- Tachycardia, Ventricular, Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT and MRIDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: CT and MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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..
Measured: 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.
Measured: 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.
Measured: 6 months after conclusion of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2025
- Study start1 Nov 2025 (estimated)
- Primary completion1 Jul 2026 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventricular Tachycardia, MonomorphicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stewart Gaede
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Stewart Gaede, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06938074
- Sponsor's protocol ID
- 126882
- Acronym
- ITPCR
- Status last verified
- Sep 2025
- First submitted
- 7 Apr 2025
- Last updated
- 26 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Imaging and Treatment Planning for Cardiac Radioablation
- ClinicalTrials.gov ID
- NCT06938074
- Acronym / sponsor ID
- ITPCR / 126882
- 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
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Stewart GaedeUniversity, hospital or other
- Study start
- 1 Nov 2025 (estimated)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 22 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CT and MRI | Experimental | Diagnostic Test: CT and MRIAll 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Ischemic cardiomyopathy with monomorphic VT
- Referred by cardiologists
- 18 years of age or older Exclusion Criteria
- • Polymorphic ventricular tachycardia
- Ventricular fibrillation
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CT and MRIAll 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. | Diagnostic test | CT and MRI |
Primary outcome
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.
Time frame: 6 months after conclusion of study
Imaging protocols will be delivered to participants. Targets will be delineated by experts. Agreement between experts will be assessed..
Adherence of treatment plans to dose constraints and deliverability of treatment plans.
Time frame: 6 months after conclusion of study
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.
1 secondary outcome
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 study
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CT and MRI in people with Ventricular Tachycardia, Monomorphic and Ventricular Tachycardia (V-Tach), run by Stewart Gaede at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 26 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stewart Gaede, PhD (519-685-8600 ext. 53144, stewart.gaede@lhsc.on.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 6 months after conclusion of study). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2025.