This clinical trial evaluates the heart-related side effects associated with magnetic resonance-guided adaptive radiation therapy (MRgART) using heart (cardiac) substructure-sparing image segmentation, compared to standard linear accelerator (LINAC)-based radiation therapy, in patients with thoracic cancers. Although radiation therapy is effective in shrinking tumors, it can also have harmful effects on organs near the tumor. One of those organs that can be negatively affected by radiation therapy is the heart. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. MRgART is a form of radiation therapy that allows the care team to watch the tumor in real time during each session using magnetic resonance imaging (MRI) and adjust the radiation treatment plan right before or even during the session if the tumor or organs have moved or changed, which may protect healthy parts of the body, like the heart. In this trial, MRgART is used with artificial intelligence-generated heart substructure images, which allows the care team to evaluate and control the amount of radiation delivered to smaller cardiac structures. LINAC is a large machine that generates high-energy x-rays to image and treat cancer based on a unique treatment plan designed just for each person. A LINAC uses a 3 dimensional x-ray image to help line up tumors before each treatment. This imaging uses a small amount of radiation to make sure the treatment is aimed correctly. MRgART used with specialized cardiac substructure-sparing image segmentation may result in lower doses of radiation delivered to smaller cardiac substructures, resulting in fewer cardiac side effects, compared to standard LINAC-based radiation therapy, in patients with thoracic tumors.
Additional locations may be listed on ClinicalTrials.gov for NCT07132918.
Locations matching your search criteria
United States
Wisconsin
Madison
University of Wisconsin Carbone Cancer Center - University HospitalStatus: Active
Contact: Carri Glide-Hurst
Phone: 608-262-5319
PRIMARY OBJECTIVE:
I. To evaluate left ventricular ejection fraction (LVEF) using cardiac MRI in subjects with thoracic cancers treated with MRgART coupled with substructure sparing as compared to subjects treated with standard of care x-ray based linac with whole heart dose/volume assessments.
SECONDARY OBJECTIVES:
I. To evaluate left and right ventricular (left ventricular [LV]/right ventricular [RV]) volumes and right ventricular ejection fraction (RVEF) using cardiac MRI in subjects with thoracic cancers treated with MRgART coupled with substructure sparing as compared to subjects treated with standard of care x-ray based linac with whole heart dose/volume assessments.
II. To evaluate myocardial strain using cardiac MRI in subjects with thoracic cancers treated with MRgART coupled with substructure sparing as compared to subjects treated with standard of care x-ray based linac with whole heart dose/volume assessments.
III. To evaluate quantitative T1, T2, and extracellular volume fraction (ECV) mapping using cardiac MRI in subjects with thoracic cancers treated with MRgART coupled with substructure sparing as compared to subjects treated with standard of care x-ray based linac with whole heart dose/volume assessments.
IV. To evaluate semi-quantitative perfusion using cardiac MRI in subjects with thoracic cancers treated with MRgART coupled with substructure sparing as compared to subjects treated with standard of care x-ray based linac with whole heart dose/volume assessments.
V. To evaluate late gadolinium enhancement interpreted by expert readers using cardiac MRI in subjects with thoracic cancers treated with MRgART coupled with substructure sparing as compared to subjects treated with standard of care x-ray based linac with whole heart dose/volume assessments.
VI. To estimate quality of life in subjects with thoracic cancers treated with MRgART coupled with substructure sparing as compared to subjects treated with standard of care x-ray based linac with whole heart dose/volume assessments.
VII. To evaluate acute toxicity of MRgART compared to that of standard of care x-ray based linac with whole heart dose/volume assessments in subjects with thoracic cancers.
CORRELATIVE OBJECTIVES:
I. To monitor heart rhythm in subjects with thoracic cancers treated with MRgART coupled with substructure sparing as compared to subjects treated with standard of care x-ray based linac with whole heart dose/volume assessments.
II. To characterize early changes in biomarkers for fibrosis and left ventricular dysfunction in subjects with thoracic cancers treated with MRgART coupled with substructure sparing as compared to subjects treated with standard of care x-ray based linac with whole heart dose/volume assessments.
III. To characterize early changes in biomarkers for myocardial injury and stress (high-sensitivity cardiac troponin T [hs-cTnT]), inflammation, and oxidative stress in subjects with thoracic cancers treated with MRgART coupled with substructure sparing as compared to subjects treated with standard of care x-ray based linac with whole heart dose/volume assessments.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients undergo MRgART with artificial intelligence-generated cardiac substructure image segmentation on each treatment day over 4-7 weeks. Patients also undergo CT at screening and undergo cardiac MRI and collection of blood samples throughout the study.
ARM II: Patients undergo standard LINAC-based radiation therapy (RT) over 4-7 weeks. Patients also undergo CT at screening and undergo cardiac MRI and collection of blood samples throughout the study.
After completion of study treatment, patients are followed up at months 3, 6, 9, and 12.
Trial PhaseNo phase specified
Trial Typetreatment
Lead OrganizationUniversity of Wisconsin Carbone Cancer Center - University Hospital
Principal InvestigatorCarri Glide-Hurst
