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Trial registered on ANZCTR


Registration number
ACTRN12618001303235
Ethics application status
Approved
Date submitted
22/06/2018
Date registered
2/08/2018
Date last updated
3/12/2020
Date data sharing statement initially provided
3/12/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Cardiac magnetic resonance imaging and Echocardiogram to investigate myocardial structural and functional changes in patients undergoing irradiation for left sided breast cancer with or without Deep Inspiration Breath Hold
Scientific title
Cardiac magnetic resonance imaging and Echocardiogram to investigate myocardial structural and functional changes in patients undergoing irradiation for left sided breast cancer with or without Deep Inspiration Breath Hold
Secondary ID [1] 295285 0
None
Universal Trial Number (UTN)
U1111-1216-1280
Trial acronym
None
Linked study record
None

Health condition
Health condition(s) or problem(s) studied:
Breast cancer 308465 0
Cardiovascular disease 308466 0
Condition category
Condition code
Cancer 307447 307447 0 0
Breast
Cardiovascular 307448 307448 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A Cardiac MRI using T1 mapping sequences to assess myocardial structural changes and a
Echocardiogram using global strain imaging to assess myocardial functional changes will be performed in women undergoing radiation therapy to the left breast, or left chest wall +/- regional nodal areas with or without deep inspiration breath hold following surgery for left sided breast cancer.
The MRI and echocardiogram will be performed between one to three weeks prior to commencement of radiation therapy (baseline) and at six months post completion of radiation therapy. The cardiac MRI will take between 45 and 60 minutes and will be performed by a cardiac MRI technician. The images will be reviewed by a Cardiologist with a special interest in cardiac MRI.
Deep inspiration breath hold (DIBH) is the process whereby the patient's breathing is monitored and, at a preset lung volume during inspiration, airflow is stopped for a short period of time, during which the radiation therapy is delivered. The duration of the breath hold and volume held is determined individually depending on what is comfortable for each patient. At the Princess Alexandra Hospital, the Elekta active breathing control (ABC) device has been used successfully for eighteen months. By holding the patient in deep inspiration, the lung expands, moving the heart away from the chest wall while the radiation beam is delivered, thus decreasing heart exposure to radiation. DIBH is monitored by the radiation therapists who are delivering the radiation treatment.
The DIBH technique is offered to all women undergoing radiation therapy for left sided breast cancer. However, some women (less than 5%) are not able to comply with this technique and therefore do not undergo DIBH. These women are being offered participation in the cardiac MRI/Echocardiogram trial to determine if there is any difference between women who are able to undergo DIBH and those who do not in the incidence of cardiac structural and functional changes as a secondary enpoint.
Patients undergoing cardiac MRI will not be asked to do the DIBH technique. However, all patients will be asked to hold their breath for short periods as part of standard protocol for cardiac MRI.
Therefore, participants may or may not undergo DIBH during radiation therapy depending on individual tolerance. Patients will not undergo DIBH during cardiac MRI but will be asked to hold their breath for short periods only as part of standard protocol for MRI.
Intervention code [1] 301615 0
Diagnosis / Prognosis
Comparator / control treatment
For the secondary endpoint, the comparator group will be women who do not undergo DIBH during radiation therapy for left sided breast cancer.
.
Control group
Active

Outcomes
Primary outcome [1] 306410 0
The incidence of myocardial structural changes (interstitial fibrosis) as measured by cardiac MRI T1 mapping sequences
Timepoint [1] 306410 0
6 months post radiation therapy for left sided breast cancer
Primary outcome [2] 306411 0
The incidence of myocardial functional changes as measured by global longitudinal strain on echocardiogram
Timepoint [2] 306411 0
Six months post radiation therapy for left sided breast cancer
Secondary outcome [1] 348482 0
The incidence of myocardial structural changes (interstitial fibrosis) as measured by cardiac MRI T1 mapping sequences in patients undergoing DIBH compared with those not undergoing DIBH during radiation therapy for left sided breast cancer.
Timepoint [1] 348482 0
Six months post completion of radiation therapy for left sided breast cancer
Secondary outcome [2] 348785 0
The incidence of myocardial functional changes as measured by global longitudinal strain on echocardiogram in patients undergoing DIBH compared with those patients not undergoing DIBH during radiation therapy for left sided breast cancer
Timepoint [2] 348785 0
Six months post completion of radiation therapy for left sided breast cancer

Eligibility
Key inclusion criteria
1. Patients with histologically proven left sided breast cancer requiring radiation therapy to either the left breast, left chest wall and or regional nodal areas (supraclavicular fossa and or internal mammary chain and or axilla)

2. Patients who are able to comply with DIBH

3. Patients who are unable to comply with DIBH

4. No contraindications to MRI

5. No contraindication to Gadolinium contrast (normal renal function)

6. Able to provide written informed consent

7. Available for follow -up
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Contraindications to MRI including but not limited to: electrically, magnetically or mechanically activated implants, vascular clips, metallic plates, cardiac stents or metal fragments in your body

2. Renal function (eGFR < 60mL/min/1.73m2)

3. Ccontraindication for Gadolinium contrast including but not limited to allergy to gadolinium

2.4. Claustrophobia

Study design
Purpose of the study
Diagnosis
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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
3/09/2018
Actual
15/09/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
30
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 11211 0
Princess Alexandra Hospital - Woolloongabba
Recruitment postcode(s) [1] 23085 0
4102 - Woolloongabba

Funding & Sponsors
Funding source category [1] 299879 0
Hospital
Name [1] 299879 0
Department of Radiation Oncology, Princess Alexandra Hospital
Country [1] 299879 0
Australia
Primary sponsor type
Hospital
Name
Princess Alexandra Hospital
Address
199 Ipswich Road
Woolloongabba
Queensland 4102
Country
Australia
Secondary sponsor category [1] 299232 0
None
Name [1] 299232 0
Address [1] 299232 0
Country [1] 299232 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300748 0
Metro South Health Human Research Ethics
Ethics committee address [1] 300748 0
Ethics committee country [1] 300748 0
Australia
Date submitted for ethics approval [1] 300748 0
05/07/2018
Approval date [1] 300748 0
30/07/2018
Ethics approval number [1] 300748 0

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

Contacts
Principal investigator
Name 84682 0
A/Prof Margot Lehman
Address 84682 0
Department of Radiation Oncology
Princess Alexandra Hospital
199 Ipswich Road
Woolloongabba
Queensland 4102
Country 84682 0
Australia
Phone 84682 0
+61 07 31762111
Fax 84682 0
Email 84682 0
Margot.Lehman@health.qld.gov.au
Contact person for public queries
Name 84683 0
Margot Lehman
Address 84683 0
Department of Radiation Oncology
Princess Alexandra Hospital
199 Ipswich Road
Woolloongabba
Queensland 4102
Country 84683 0
Australia
Phone 84683 0
+61 07 3176 2111
Fax 84683 0
Email 84683 0
Margot.Lehman@health.qld.gov.au
Contact person for scientific queries
Name 84684 0
Margot Lehman
Address 84684 0
Department of Radiation Oncology
Princess Alexandra Hospital
199 Ipswich Road
Woolloongabba
Queensland 4102
Country 84684 0
Australia
Phone 84684 0
+61 07 31762111
Fax 84684 0
Email 84684 0
Margot.Lehman@health.qld.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.