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
Other study identifiers
Sponsor study identifier
observational
15
1 country
1
Study Start
January 1, 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
December 31, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 31, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry Overview
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
- Recruitment status
- unknown
- Estimated enrollment
- 15 participants
- Study completion date
December 31, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
- Listed locations
- 1 countries · 1 sites
Trial Relationships
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Study Timeline
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
First Submitted
November 16, 2018
Actual (reported)First Posted
November 20, 2018
Actual (reported)Study Start
January 1, 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
December 31, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 31, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
- Last Updated
- November 27, 2018
- Status Verified
- November 2018
- Last Update Submitted
- November 23, 2018