Hybrid PET/MR Imaging of Acute Cardiac Inflammation After Left-Sided Breast Cancer Radiotherapy
RICT-BREAST
Assessing Acute Cardiac Inflammation After Left-Sided Breast Cancer Radiotherapy With Hybrid PET/MRI
1 other identifier
observational
15
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jan 2019
Typical duration for all trials
1 active site
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 16, 2018
CompletedFirst Posted
Study publicly available on registry
November 20, 2018
CompletedStudy Start
First participant enrolled
January 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2021
CompletedNovember 27, 2018
November 1, 2018
2 years
November 16, 2018
November 23, 2018
Conditions
Outcome Measures
Primary Outcomes (5)
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)).
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)).
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.
one month
Detection of Imaging Biomarkers of late cardiac perfusion changes
N-13 Ammonia PET imaging to detect changes in late cardiac perfusion changes
one year
Detection of cardiac fibrosis
Gadolinium Enhanced MR imaging to detect cardiac fibrosis compared to baseline
one year
Study Arms (1)
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.
Interventions
Left-Sided Patients will receive standard radiation therapy, including 42.5 Gy in 16 fractions or 50 Gy in 25 fractions.
Eligibility Criteria
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.
You may qualify if:
- 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
- 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
You may not qualify if:
- 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)
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Lawson Health Research Institute
London, Ontario, N6C 2R5, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Stewart Gaede, PhD
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 16, 2018
First Posted
November 20, 2018
Study Start
January 1, 2019
Primary Completion
December 31, 2020
Study Completion
December 31, 2021
Last Updated
November 27, 2018
Record last verified: 2018-11
Data Sharing
- IPD Sharing
- Will not share