Left-Sided Breast CancerRICT-BREASTNCT03748030
Hybrid PET/MR Imaging of Acute Cardiac Inflammation After Left-Sided Breast Cancer Radiotherapy
An observational study of Left-Sided Breast Cancer and Radiation Toxicity, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
Trial summary
Radiation therapy (RT) of the breast is a critical component of modern breast cancer treatment. RT treatments have led to improved local control and overall survival of breast cancer patients. However, the incidence of radiation induced harmful effects is increasing in these patients. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Left-Sided Breast Cancer, Radiation Toxicity
- What is being tested?
- Confirmed Left-Sided Breast Cancer
- Type of treatment
- Surgery or procedure
- How many people
- 15 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jan 2019to 31 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Ultimately, the sample size was based upon practical considerations and that 15 breast cancer patients could be accrued relatively easily from new patient clinics, while sufficiently providing enough evidence to validate the imaging techniques to be used as a non-invasive measure for future clinical trials aimed at reducing or mitigating radiation-induced cardiac toxicity.
Who may be able to join
- Age 18 or older
- Ability to provide informed consent
- Histologically evidence of left-sided breast cancer where potentially curative treatment is planned
- T1/T2 N0, T1/T2 N1, T3/T4 and/or N2/N3 according to Tumor-Node-Metastases (TNM) staging criteria
- All patients to receive prescription dose according to current London Regional Cance Program (LRCP) standards
- No prior RT to the thorax
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- Eastern Cooperative Oncology Group (ECOG) performance status 0-2 within one month of accrual
- Satisfactory pulmonary function as determined by the treating radiation oncologist
- Expected lifespan at least 1 year
- Negative pregnancy test within one month of accrual if woman is premenopausal
Who cannot join
- No current or recurring atrial fibrillation
- Previous coronary bypass surgery
- Patients with severe reversible airways obstruction
- Patients with acute coronary syndrome (STEMI/non-STEMI and unstable angina)
- Atrioventricular block without pacemaker
- Patients who are renal insufficient (eGFR <40)
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- Patients with asthma
- Allergy to gadolinium for scans using contrast; will be eligible for non-contrast scans.
- Other contraindications to gadolinium contrast media as determined by the research team.
- Relative contraindications to PET (e.g. uncontrolled diabetes, claustrophobia, inability to be still for 60 minutes
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessing Acute Cardiac Inflammation After Left-Sided Breast Cancer Radiotherapy With Hybrid PET/MRI
Radiation therapy (RT) of the breast is a critical component of modern breast cancer treatment. RT treatments have led to improved local control and overall survival of breast cancer patients. However, the incidence of radiation induced harmful effects is increasing in these patients. This is because in delivering RT, it is difficult to completely avoid surrounding non-cancerous normal tissue, including the heart. The main concern here is that radiation induced effects on the heart may lead to an increased risk of cardiovascular disease later in a patient's life, potentially many years after radiation. Despite methods that can detect alterations in blood flow one to two years following radiotherapy, knowledge of early radiation effects to the heart is still limited. A previous animal experiment performed by our group involved delivering a radiation dose to the heart in a manner similar to the way a heart would be exposed, during radiotherapy for a cancer involving the left breast. Taking several images over the months following radiation with a new imaging technique, hybrid PET/MRI, has suggested an increase in inflammation can be detected as early as one-week following irradiation and may be the triggering event for cardiac disease seen in women 10-15 years after radiotherapy. The investigators propose a pilot study where 15 left-sided breast cancer patients undergoing radiotherapy will be imaged before, as well as one week and one-year post radiotherapy with our hybrid PET/MRI scanner. Areas of inflammation, changes in blood flow, and scar formation within the heart, will be measured by looking at the difference between images that are taken after radiation treatment to the images taken before treatment. The expectation is that any areas of the heart that show detectable differences in the images will be directly related to how much radiation was deposited in those areas. The information gained from this pilot study which will correlate the amount of radiation administered to the degree and extent of injury will help aid in the design of new treatment strategies, that can hopefully decrease or eliminate inadvertent heart damage, thereby, improving the quality of life for breast cancer patients.
Read the detailed description
Goals: The overall goal of this study is to identify the presence of acute low-dose radiation induced cardiac toxicity, including inflammation, in left-sided breast cancer patients undergoing radiotherapy using hybrid positron emission tomography (PET) and magnetic resonance imaging (MRI).
Methodology: A imaging pilot study composed of 15 left-sided breast cancer patients receiving standard radiotherapy is proposed. Patients will be imaged at baseline, within the first month post radiotherapy, and within the first-year post radiotherapy using a hybrid 3T-PET/MRI system (Biograph mMR, Siemens Healthcare). The PET imaging protocol is designed to assess changes in both myocardial perfusion and inflammation. The MR imaging protocol, acquired simultaneously, will be used to identify heart volume, wall motion, mature fibrosis or scar.
Outcome: The findings of this studies will validate the utility of hybrid PET/MRI to detect early inflammatory response, changes in myocardial perfusion, and heart function as a function of radiation dose in a human breast cancer population. This will allow consideration of new techniques to minimize or eliminate heart complications to future cancer patients and provide a non-invasive technique to serially image patients post radiotherapy and to investigate the effect of new interventions. Success of this study will stem from a unique collaboration of Radiation Oncologists, Medical Physicists, Imaging Scientists, and Cardiologists.
- Conditions
- Left-Sided Breast Cancer, Radiation Toxicity
- Being tested
- Confirmed Left-Sided Breast Cancer
- Medical subject headings
- Unilateral Breast Neoplasms, Radiation Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Confirmed Left-Sided Breast CancerRadiation
Left-Sided Patients will receive standard radiation therapy, including 42.5 Gy in 16 fractions or 50 Gy in 25 fractions.
| Study group | Role | What they receive |
|---|---|---|
| Confirmed Left-Sided Breast Cancer | T1/T2 N0, T1/T2 N1, T3/T4 and/or N2/N3 Left-Sided Breast Cancer Patients receiving standard radiation therapy will receive PET/MRI, ECG/EKG, and bloodwork before, within a month, and within a year post treatment. Receives: Radiation: Confirmed Left-Sided Breast Cancer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of Imaging Biomarkers of acute cardiac inflammation
18F-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose (FDG)-PET imaging to detect increase in cardiac inflammation compared to baseline with corresponding blood markers (Erythrocyte Sedimentation Rate (ESR), high sensitivity C-reactive protein, and troponin levels in blood (inflammation)).
Measured: one month
Detection of Imaging Biomarkers of late cardiac inflammation
FDG-PET imaging to detect increase in cardiac inflammation compared to baseline with corresponding blood markers (Erythrocyte Sedimentation Rate (ESR), high sensitivity C-reactive protein, and troponin levels in blood (inflammation)).
Measured: one year
Detection of Imaging Biomarkers of acute cardiac perfusion changes
N-13 Ammonia PET imaging to detect changes in acute cardiac perfusion changes compared to baseline.
Measured: one month
Detection of Imaging Biomarkers of late cardiac perfusion changes
N-13 Ammonia PET imaging to detect changes in late cardiac perfusion changes
Measured: one year
Detection of cardiac fibrosis
Gadolinium Enhanced MR imaging to detect cardiac fibrosis compared to baseline
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2018
- Study start1 Jan 2019 (estimated)
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Left-Sided Breast CancerStudies of the same condition, open and under way.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stewart Gaede, PhD, Principal investigator, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03748030
- Sponsor's protocol ID
- 112991
- Acronym
- RICT-BREAST
- Status last verified
- Nov 2018
- First submitted
- 16 Nov 2018
- Last updated
- 27 Nov 2018
- 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 27 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Acute Cardiac Inflammation After Left-Sided Breast Cancer Radiotherapy With Hybrid PET/MRI
- ClinicalTrials.gov ID
- NCT03748030
- Acronym / sponsor ID
- RICT-BREAST / 112991
- Conditions
- Left-Sided Breast Cancer, Radiation Toxicity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Study start
- 1 Jan 2019 (estimated)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 20 Nov 2018 (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.
Radiation therapy (RT) of the breast is a critical component of modern breast cancer treatment. RT treatments have led to improved local control and overall survival of breast cancer patients. However, the incidence of radiation induced harmful effects is increasing in these patients. This is because in delivering RT, it is difficult to completely avoid surrounding non-cancerous normal tissue, including the heart. The main concern here is that radiation induced effects on the heart may lead to an increased risk of cardiovascular disease later in a patient's life, potentially many years after radiation. Despite methods that can detect alterations in blood flow one to two years following radiotherapy, knowledge of early radiation effects to the heart is still limited. A previous animal experiment performed by our group involved delivering a radiation dose to the heart in a manner similar to the way a heart would be exposed, during radiotherapy for a cancer involving the left breast. Taking several images over the months following radiation with a new imaging technique, hybrid PET/MRI, has suggested an increase in inflammation can be detected as early as one-week following irradiation and may be the triggering event for cardiac disease seen in women 10-15 years after radiotherapy. The investigators propose a pilot study where 15 left-sided breast cancer patients undergoing radiotherapy will be imaged before, as well as one week and one-year post radiotherapy with our hybrid PET/MRI scanner. Areas of inflammation, changes in blood flow, and scar formation within the heart, will be measured by looking at the difference between images that are taken after radiation treatment to the images taken before treatment. The expectation is that any areas of the heart that show detectable differences in the images will be directly related to how much radiation was deposited in those areas. The information gained from this pilot study which will correlate the amount of radiation administered to the degree and extent of injury will help aid in the design of new treatment strategies, that can hopefully decrease or eliminate inadvertent heart damage, thereby, improving the quality of life for breast cancer patients.
Detailed description
Goals: The overall goal of this study is to identify the presence of acute low-dose radiation induced cardiac toxicity, including inflammation, in left-sided breast cancer patients undergoing radiotherapy using hybrid positron emission tomography (PET) and magnetic resonance imaging (MRI).
Methodology: A imaging pilot study composed of 15 left-sided breast cancer patients receiving standard radiotherapy is proposed. Patients will be imaged at baseline, within the first month post radiotherapy, and within the first-year post radiotherapy using a hybrid 3T-PET/MRI system (Biograph mMR, Siemens Healthcare). The PET imaging protocol is designed to assess changes in both myocardial perfusion and inflammation. The MR imaging protocol, acquired simultaneously, will be used to identify heart volume, wall motion, mature fibrosis or scar.
Outcome: The findings of this studies will validate the utility of hybrid PET/MRI to detect early inflammatory response, changes in myocardial perfusion, and heart function as a function of radiation dose in a human breast cancer population. This will allow consideration of new techniques to minimize or eliminate heart complications to future cancer patients and provide a non-invasive technique to serially image patients post radiotherapy and to investigate the effect of new interventions. Success of this study will stem from a unique collaboration of Radiation Oncologists, Medical Physicists, Imaging Scientists, and Cardiologists.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Confirmed Left-Sided Breast Cancer | – | Radiation: Confirmed Left-Sided Breast CancerT1/T2 N0, T1/T2 N1, T3/T4 and/or N2/N3 Left-Sided Breast Cancer Patients receiving standard radiation therapy will receive PET/MRI, ECG/EKG, and bloodwork before, within a month, and within a year post treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Ultimately, the sample size was based upon practical considerations and that 15 breast cancer patients could be accrued relatively easily from new patient clinics, while sufficiently providing enough evidence to validate the imaging techniques to be used as a non-invasive measure for future clinical trials aimed at reducing or mitigating radiation-induced cardiac toxicity.
Key inclusion criteria (10 listed)
- Age 18 or older
- Ability to provide informed consent
- Histologically evidence of left-sided breast cancer where potentially curative treatment is planned
- T1/T2 N0, T1/T2 N1, T3/T4 and/or N2/N3 according to Tumor-Node-Metastases (TNM) staging criteria
- All patients to receive prescription dose according to current London Regional Cance Program (LRCP) standards
Key exclusion criteria (10 listed)
- No current or recurring atrial fibrillation
- Previous coronary bypass surgery
- Patients with severe reversible airways obstruction
- Patients with acute coronary syndrome (STEMI/non-STEMI and unstable angina)
- Atrioventricular block without pacemaker
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 |
|---|---|---|
| Confirmed Left-Sided Breast CancerLeft-Sided Patients will receive standard radiation therapy, including 42.5 Gy in 16 fractions or 50 Gy in 25 fractions. | Radiation | Confirmed Left-Sided Breast Cancer |
Primary outcome
Detection of Imaging Biomarkers of acute cardiac inflammation
Time frame: one month
18F-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose (FDG)-PET imaging to detect increase in cardiac inflammation compared to baseline with corresponding blood markers (Erythrocyte Sedimentation Rate (ESR), high sensitivity C-reactive protein, and troponin levels in blood (inflammation)).
Detection of Imaging Biomarkers of late cardiac inflammation
Time frame: one year
FDG-PET imaging to detect increase in cardiac inflammation compared to baseline with corresponding blood markers (Erythrocyte Sedimentation Rate (ESR), high sensitivity C-reactive protein, and troponin levels in blood (inflammation)).
Detection of Imaging Biomarkers of acute cardiac perfusion changes
Time frame: one month
N-13 Ammonia PET imaging to detect changes in acute cardiac perfusion changes compared to baseline.
Detection of Imaging Biomarkers of late cardiac perfusion changes
Time frame: one year
N-13 Ammonia PET imaging to detect changes in late cardiac perfusion changes
Detection of cardiac fibrosis
Time frame: one year
Gadolinium Enhanced MR imaging to detect cardiac fibrosis compared to baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2018.
- 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. This study is not recruiting at the moment.
Stewart Gaede, PhD principal investigator
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Left-Sided Breast Cancer and Radiation Toxicity, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's 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 10 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 27 Nov 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Stewart Gaede, PhD (519-685-8500 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?
Detection of Imaging Biomarkers of acute cardiac inflammation (time frame: one month). The study lists 5 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 27 Nov 2018.