Detecting Radiation-Induced Cardiac Toxicity After Non-Small Cell Lung Cancer Radiotherapy
RICT-LUNG
Identification of Acute Radiation-induced Cardiac Toxicity After Non-small Cell Lung Cancer Radiotherapy With Advanced Multi-modality Imaging (RICT-LUNG)
Other study identifiers
Sponsor study identifier
observational
20
1 country
1
Study Start
January 11, 2018
Actual (reported)Primary Completion
March 1, 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
March 1, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Brief Summary
Lung cancer is the most common cause of cancer death in Canada. For approximately 30% of patients that present with locally-advanced non-small cell lung cancer (NSCLC), the standard treatment is curative-intent concurrent chemoradiotherapy. Outcomes remain poor, with 5-year survival of only 20%. Despite the long-held belief that higher radiation doses lead to improved overall survival (OS), the landmark randomized trial (RTOG 0617) showed the opposite. The investigators hypothesize that the inferior survival observed may be due to unexpected heart toxicity as secondary analysis revealed that the heart dose was a strong predictor of inferior OS. Up to now, change in heart function is typically detected histologically, requiring autopsy tissue. Therefore, a non-invasive marker of early heart damage is required. Hybrid PET-MRI has become available in Canada only recently. The ability to simultaneously perform metabolic imaging with functional and tissue imaging allows for novel assessment of heart toxicity. The primary objective is to examine the utility of hybrid PET-MRI and DCE-CT to assess acute changes in heart function and to measure inflammation before, and six weeks after NSCLC radiotherapy. A pilot of 20 patients with Stage I-III NSCLC will be enrolled. The findings of this study will aid in the design of new studies to reassess dose escalation for locally advanced NSCLC while limiting the risk of heart toxicity. FDG PET will be used to simultaneously assess both cardiac inflammation and tumour response. Quantitative DCE-CT will also be used to measure ventilation and perfusion changes in the normal lung and tumour after radiotherapy, providing image data that can comprehensively assess both tumour response and potential toxicity in both the heart and lungs. Such information is crucial in understanding the disease and its response to treatment. This data will also aid in the design of radiation techniques that spare the heart in other patients with any thoracic malignancies, including breast cancer, lymphoma, and esophageal cancer.
Registry Overview
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
- Recruitment status
- unknown
- Estimated enrollment
- 20 participants
- Study completion date
March 1, 2020
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
December 22, 2017
Actual (reported)Study Start
January 11, 2018
Actual (reported)First Posted
January 31, 2018
Actual (reported)Primary Completion
March 1, 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
March 1, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
- Last Updated
- January 31, 2018
- Status Verified
- January 2018
- Last Update Submitted
- January 24, 2018