Detecting Radiation-Induced Cardiac Toxicity After Non-Small Cell Lung Cancer Radiotherapy (RICT-LUNG)
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|ClinicalTrials.gov Identifier: NCT03416972|
Recruitment Status : Recruiting
First Posted : January 31, 2018
Last Update Posted : January 31, 2018
|Condition or disease||Intervention/treatment|
|Non-small Cell Lung Cancer Radiation Toxicity||Radiation: Standard platinum-based chemoradiotherapy|
|Study Type :||Observational|
|Estimated Enrollment :||20 participants|
|Official Title:||Identification of Acute Radiation-induced Cardiac Toxicity After Non-small Cell Lung Cancer Radiotherapy With Advanced Multi-modality Imaging (RICT-LUNG)|
|Actual Study Start Date :||January 11, 2018|
|Estimated Primary Completion Date :||March 1, 2019|
|Estimated Study Completion Date :||March 1, 2020|
Stage I-III NSCLC patients
Stage I/II NSCLC patients receiving standard stereotactic body radiation therapy and Stage III patients receiving Standard platinum-based chemoradiotherapy will receive PET/MRI, DCE-CT, ECG/EKG, and bloodwork before and six weeks post treatment.
Radiation: Standard platinum-based chemoradiotherapy
Stage III patients: Standard platinum-based chemotherapy, total radiation dose 60 Gy in 30 fractions. Stage I/II patients: Standard radiotherapy, total radiation dose of 54 Gy in 3 fractions (peripheral), 55 Gy in 5 fractions (near chest wall), or 60 Gy in 8 fractions (central).
- Detection of Imaging Biomarkers of acute cardiac inflammation [ Time Frame: 6 weeks ]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: 6 weeks ]DCE-CT imaging to detect changes in acute cardiac perfusion changes compared to baseline.
- Detection of Imaging Biomarkers of acute changes in Left-ventricular ejection fraction (LVEF) [ Time Frame: 6 weeks ]Contrast-enhanced CT imaging to detect acute changes in LVEF compared to baseline.
- Detection of cardiac fibrosis [ Time Frame: 6 weeks ]Gadolinium Enhanced MR imaging to detect cardiac fibrosis compared to baseline
- Tumour Response (metabolism) [ Time Frame: 6 weeks ]FDG-PET imaging to detect tumour metabolism changes compared to baseline.
- Tumour Response (perfusion) [ Time Frame: 6 weeks ]DCE-CT imaging to detect changes in tumour perfusion compared to baseline
- Acute Changes in Lung Ventilation [ Time Frame: 6 weeks ]4D-CT imaging to detect changes in lung ventilation compared to baseline
- Acute Changes in Lung Perfusion [ Time Frame: 6 weeks ]DCE-CT imaging to detect changes in lung perfusion compared to baseline
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03416972
|Contact: Stewart Gaede, PhD||519-685-8600 ext firstname.lastname@example.org|
|Contact: Anne O'Connell||519-685-8500 ext email@example.com|
|Lawson Health Research Institute||Recruiting|
|London, Ontario, Canada, N6C 2R5|
|Contact: James Sinfield 519-685-8500 ext 53349 firstname.lastname@example.org|
|Contact: Albert Gratton 519-685-8500 ext 53233 email@example.com|
|Principal Investigator: Stewart Gaede, PhD|
|Principal Investigator:||Stewart Gaede, PhD||Lawson Health Research Institute|