Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001080718p
Ethics application status
Not yet submitted
Date submitted
28/07/2022
Date registered
4/08/2022
Date last updated
4/08/2022
Date data sharing statement initially provided
4/08/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Stereotactic Body Radiotherapy for Ventricular Tachycardia (CARDIAC SBRT)
Scientific title
A Prospective Cohort Study assessing the feasibility, efficacy and safety of Cardiac Stereotactic Body Radiotherapy (SBRT) in patients with Ventricular Tachycardia (VT)
Secondary ID [1] 307667 0
Nil
Universal Trial Number (UTN)
Trial acronym
CARDIAC SBRT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ventricular Tachycardia (VT) 327195 0
Condition category
Condition code
Cardiovascular 324335 324335 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
1. Cardiac Magnetic Resonance Imaging (MRI) with IV Gadolinum within 14 days of enrolment at the Princess Alexandra Hospital (PAH) Radiology department to assess patient's heart. This will take approximately 30 mins. Assessment by the cardiologist, radiologist and treating Radiation Oncologist (RO) at PAH. This may be done on the same day as the PET Scan.
2. MRI 48 hours, 3 months and 12 months post completion of Stereotactic Body Radiotherapy (SBRT) to assess local oedema, any acute injury such as pericardial effusion and evaluate late fibrotic changes. Assessment carried out by cardiologists at the PAH. Each scan will take approximately 30mins.
3. Positron Emissions Testing (PET) within 14 days of enrollment at the PAH Radiology Department to identify areas of inflammation and ischaemia to assist in the delineation of the proposed SBRT treatment volume assessed by cardiologists, radiologists and treating RO. This scan will take approximately 1 hour and may be done on the same day as the Cardiac MRI.
4. Planning for the SBRT. This involves the patient attending the Radiation Oncology Department at the PAH. The patient will positioned on a robotic bed, and may be asked to lie on a special bean bag. When the air is removed from the bean bag, this creates a mould around the patient to assist the patient in keeping still during the planning and treatment. This is so that the patient is in the same position as when the treatment is planned. Whilst lying in this bean bag, a special machine called an MRI-Sim will take a Computerised Tomography (CT) Scan and MRI to assist in the delineation of the proposed SBRT Treatment volume by the treating RO. This process will take approximately 1 hour.
5. The SBRT treatment delivered at the PAH radiation therapy unit by Qualified Radiation therapists and is usually about 5-7 days after the planning session. The patient will lie on a robotic bed in the same position as the planning session and will be moved under a machine called a linear accelerator. This machine produces high energy xrays to deliver the SBRT treatment directed at the heart. The patient needs lie very still whilst the having the treatment however there is nothing to see or feel when the treatment is being given. The radiation therapists will move the linear accelerator around the patient to deliver multiple xray beams from different angles to ensure the entire area receives the prescribed treatment dose. The whole process may take a little under one hour, however the actual time the linear accelerator is delivering xrays may only be a few seconds from each angle. The dose prescribed for this treatment is 25Gy given in one single treatment.
6. Evaluation of ICD immediately using electrocardiograms (ECG) before and immediately after SBRT will assess any immediate side effects of the treatment. This involves having electrodes placed on the chest to record the heart's electrical signals. This will be conducted by the cardiologists at the PAH and will take approx 30 minutes each.
Intervention code [1] 324138 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 332138 0
Feasibility assessed by the number of patients able to complete planning, treatment and follow-up as determined by the number of visits completed as per the protocol schedule. Data collected during routine physical examinations, patient interviews via clinic visits or phone call and review of medical records.
Timepoint [1] 332138 0
Baseline, day of SBRT, Day 3 post completion of SBRT, 2 weeks post completion of SBRT, 4 weeks post completion of SBRT, 6 weeks post completion of SBRT, 3 months post completion of SBRT, 6 months post completion of SBRT, 12 months post completion of SBRT, 18 months post completion of SBRT, 24 months post completion of SBRT
Primary outcome [2] 332147 0
Safety assessed as adverse events (including but not limited to chest pain, fatigue, cardiac events) as determined clinician assessment using Common Terminology Criteria for Adverse Events (CTCAE5.0), patient interviews via clinic visits or phone call and review of medical records.
Timepoint [2] 332147 0
Baseline, day of SBRT, Day 3 post completion of SBRT, 2 weeks post completion of SBRT, 4 weeks post completion of SBRT, 6 weeks post completion of SBRT, 3 months post completion of SBRT, 6 months post completion of SBRT, 12 months post completion of SBRT, 18 months post completion of SBRT, 24 months post completion of SBRT
Secondary outcome [1] 412329 0
Effectiveness assessed as a composite outcome, by comparing the number of patients and number of events requiring treatment for VT with an Implantable Cardioverter Defibrillator (ICD) by clinician review, patient interviews via clinic visits or phone call and review of medical records.
Timepoint [1] 412329 0
three months prior to SBRT, Baseline, day of SBRT, Day 3 post completion of SBRT, 2, 4 and 6 weeks post completion of SBRT, 3, 6, 12, 18 and 24 months post completion of SBRT,
Secondary outcome [2] 412330 0
Evaluate overall survival by data collected during routine physical examinations, patient interviews via clinic visits or phone call and review of medical records.
Timepoint [2] 412330 0
6, 12, and 24 months post-completion of SBRT
Secondary outcome [3] 412331 0
Evaluate patient reported quality of life (PR-QOL) using Boston Health Research Institute 36-item Short Form Health Survey (SF-36)
Timepoint [3] 412331 0
Baseline, 6 weeks post completion of SBRT, 3, 6, 12, 18 and 24 months post-completion of SBRT
Secondary outcome [4] 412332 0
Evaluate requirement of in anti-arrhythmic medications (number, type and dose) assessed by data collected during routine physical examinations, patient interviews via clinic visits or phone call and review of medical records.
Timepoint [4] 412332 0
Baseline, 6 weeks post completion of SBRT, 3, 6, 12, 18 and 24 months post-completion of SBRT

Eligibility
Key inclusion criteria
Documented sustained ventricular tachycardia (VT) with at least 3 episodes of VT in 12 months prior to enrollment

Require at least 1 anti-arrhythmic medication

Failed at least 1 invasive catheter ablation procedure, or have contraindications to invasive catheter ablation

Assessed as able to tolerate radiotherapy planning, immobilisation and treatment as deemed by the radiation oncologist

Willing and able to provide informed consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Previous radiotherapy to the chest with any radiation dose to the heart

Advanced heart failure (NYHA Class IV)

High-volume myocardial scar substrate to such an extent that treatment with Stereotactic Body Radiotherapy (SBRT) is deemed unsafe by the radiation oncologist

Ventricular Tachycardia (VT) deemed not to be related to a definable myocardial scar

Competing comorbidities (unrelated to VT) which limit life expectancy to less than 6 months.

Must not be pregnant and/or breastfeeding if female; must have a negative pregnancy test within 7 days of study enrollment.

Implantable Cardiac Defibrillator (ICD) implanted less than 6 weeks prior

Renal failure or allergy precluding administration of Intravenous (IV) gadolinium

Computer Tomography (CT) IV contrast allergy

Any concurrent anti-neoplastic therapy

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Baseline characteristics will be summarised in frequency tables and by the use of descriptive statistics for quantitative variables (CTCv4.0).

Time-to-event curves for acute and late toxicity, and overall survival will be constructed using the Kaplan-Meier method with the log-rank test used to determine the magnitude of differences.

The QOL will be assessed using a validated quality of life tool

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
3/10/2022
Actual
Date of last participant enrolment
Anticipated
1/10/2024
Actual
Date of last data collection
Anticipated
5/10/2026
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 22881 0
Princess Alexandra Hospital - Woolloongabba
Recruitment postcode(s) [1] 38186 0
4102 - Woolloongabba

Funding & Sponsors
Funding source category [1] 311935 0
Hospital
Name [1] 311935 0
Metro South Hospital
Country [1] 311935 0
Australia
Primary sponsor type
Hospital
Name
Metro South Hospital
Address
199 Ipswich Road
Woolloongabba 4102
Queensland
Country
Australia
Secondary sponsor category [1] 313418 0
None
Name [1] 313418 0
Address [1] 313418 0
Country [1] 313418 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 311368 0
Metro South Hospital Human Research Ethics Committee
Ethics committee address [1] 311368 0
Ethics committee country [1] 311368 0
Australia
Date submitted for ethics approval [1] 311368 0
05/09/2022
Approval date [1] 311368 0
Ethics approval number [1] 311368 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 120854 0
Dr Michael Huo
Address 120854 0
Radiation Oncology Department
Princess Alexandra Hospital
199 Ipswich Road
Woolloongabba, 4102
Queensland
Country 120854 0
Australia
Phone 120854 0
+61 7 3176 1987
Fax 120854 0
Email 120854 0
[email protected]
Contact person for public queries
Name 120855 0
Michael Huo
Address 120855 0
Radiation Oncology Department
Princess Alexandra Hospital
199 Ipswich Road
Woolloongabba, 4102
Queensland
Country 120855 0
Australia
Phone 120855 0
+61 7 3176 1987
Fax 120855 0
Email 120855 0
[email protected]
Contact person for scientific queries
Name 120856 0
Michael Huo
Address 120856 0
Radiation Oncology Department
Princess Alexandra Hospital
199 Ipswich Road
Woolloongabba, 4102
Queensland
Country 120856 0
Australia
Phone 120856 0
+61 7 3176 1987
Fax 120856 0
Email 120856 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
all of the individual participant data collected during the trial, after de-identification
When will data be available (start and end dates)?
Case-by-case basis at the discretion of Primary Sponsor following publication, no end date
Available to whom?
case-by-case basis at the discretion of Primary Sponsor
Available for what types of analyses?
case-by-case basis at the discretion of Primary Sponsor
How or where can data be obtained?
access subject to approvals by Principal Investigator:
[email protected]


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.