NCT03416972: RICT-LUNG

Detecting Radiation-Induced Cardiac Toxicity After Non-Small Cell Lung Cancer Radiotherapy

Status unknown Last updated 31 January 2018

What this trial tests

trial testing Standard platinum-based chemoradiotherapy in Non-small Cell Lung Cancer in 20 participants. Status unknown.

Timeline

11 January 2018

Primary endpoint
1 March 2019

1 March 2020

Quick facts

Lead sponsor	London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Status	Status unknown
Study type	OBSERVATIONAL
Enrollment	20
Start date	11 January 2018
Primary completion	1 March 2019
Estimated completion	1 March 2020
Sites	1 location across Canada

Drugs / interventions tested

• Standard platinum-based chemoradiotherapy

Conditions studied

• Non-small Cell Lung Cancer — all drugs for Non-small Cell Lung Cancer →
• Radiation Toxicity — all drugs for Radiation Toxicity →

Sponsor

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Who can join

Eligibility, any sex, with Non-small Cell Lung Cancer or Radiation Toxicity. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Multimodality Imaging Assessment of the Heart Before and After Stage III Non-small Cell Lung Cancer Radiation Therapy.
   Chau OW, Islam A, Yu E, Qu M, et al · · 2022 · PMID 35434423 · DOI 10.1016/j.adro.2022.100927