Hybrid PET/MR Imaging of Acute Cardiac Inflammation After Left-Sided Breast Cancer Radiotherapy (RICT-BREAST)
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|ClinicalTrials.gov Identifier: NCT03748030|
Recruitment Status : Not yet recruiting
First Posted : November 20, 2018
Last Update Posted : November 27, 2018
|Condition or disease||Intervention/treatment|
|Left-Sided Breast Cancer Radiation Toxicity||Radiation: Confirmed Left-Sided Breast Cancer|
Goals: The overall goal of this study is to identify the presence of acute low-dose radiation induced cardiac toxicity, including inflammation, in left-sided breast cancer patients undergoing radiotherapy using hybrid positron emission tomography (PET) and magnetic resonance imaging (MRI).
Methodology: A imaging pilot study composed of 15 left-sided breast cancer patients receiving standard radiotherapy is proposed. Patients will be imaged at baseline, within the first month post radiotherapy, and within the first-year post radiotherapy using a hybrid 3T-PET/MRI system (Biograph mMR, Siemens Healthcare). The PET imaging protocol is designed to assess changes in both myocardial perfusion and inflammation. The MR imaging protocol, acquired simultaneously, will be used to identify heart volume, wall motion, mature fibrosis or scar.
Outcome: The findings of this studies will validate the utility of hybrid PET/MRI to detect early inflammatory response, changes in myocardial perfusion, and heart function as a function of radiation dose in a human breast cancer population. This will allow consideration of new techniques to minimize or eliminate heart complications to future cancer patients and provide a non-invasive technique to serially image patients post radiotherapy and to investigate the effect of new interventions. Success of this study will stem from a unique collaboration of Radiation Oncologists, Medical Physicists, Imaging Scientists, and Cardiologists.
|Study Type :||Observational|
|Estimated Enrollment :||15 participants|
|Official Title:||Assessing Acute Cardiac Inflammation After Left-Sided Breast Cancer Radiotherapy With Hybrid PET/MRI|
|Estimated Study Start Date :||January 1, 2019|
|Estimated Primary Completion Date :||December 31, 2020|
|Estimated Study Completion Date :||December 31, 2021|
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.
Radiation: Confirmed Left-Sided Breast Cancer
Left-Sided Patients will receive standard radiation therapy, including 42.5 Gy in 16 fractions or 50 Gy in 25 fractions.
- Detection of Imaging Biomarkers of acute cardiac inflammation [ Time Frame: one month ]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)).
- Detection of Imaging Biomarkers of late cardiac inflammation [ Time Frame: one year ]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: one month ]N-13 Ammonia PET imaging to detect changes in acute cardiac perfusion changes compared to baseline.
- Detection of Imaging Biomarkers of late cardiac perfusion changes [ Time Frame: one year ]N-13 Ammonia PET imaging to detect changes in late cardiac perfusion changes
- Detection of cardiac fibrosis [ Time Frame: one year ]Gadolinium Enhanced MR imaging to detect cardiac fibrosis 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): NCT03748030
|Contact: Stewart Gaede, PhD||519-685-8500 ext firstname.lastname@example.org|
|Contact: Anne O'Connell||519-685-8500 ext email@example.com|
|Lawson Health Research Institute|
|London, Ontario, Canada, N6C 2R5|
|Principal Investigator:||Stewart Gaede, PhD||Lawson Health Research Institute|