Cardiac Function in Patients Undergoing Proton Beam or Photon Radiotherapy
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 15-007443
Sponsor Protocol Number: 15-007443
About this study
The purpose of this study is to determine whether conventional or new (2D- speckle tracking echocardiography) parameters of left and right ventricular function are impaired during and at the end of proton beam or photon radiotherapy.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Histological diagnosis of thoracic neoplasia and cardiac exposure from curative intent proton beam or photon radiotherapy:
- Esophageal cancer (stages I, II, III);
- Lung cancer (stages I, II and III and recurrent non-small cells lung cancer and small cells lung cancer and thymoma);
- Breast cancer (stage I, stage II, stage III or recurrent undergoing regional nodal irradiation);
- Hodgkin’s lymphoma (stages I, II, III, IV) and non-Hodgkin’s lymphoma (stages I, II, III).
- Anticipated mean heart dose ≥ 1 Gy with a photon radiotherapy plan.
Absolute Exclusion Criteria:
- Inadequate image quality.
- Irregular R-R Interval.
- Age < 18 years.
Relative Exclusion Criteria:
- Previous cardiovascular diseases (myocardial infarction, congestive heart failure, and cardiomyopathy): patients with prior thoracic radiotherapy may be enrolled and undergo a baseline echocardiogram. Patients will be excluded if the baseline echocardiogram is abnormal.
- Moderate or severe valvular stenosis or regurgitation.
- Uncontrolled hypertension.
- Prior thoracic radiotherapy: patients with prior thoracic radiotherapy may be enrolled and undergo a baseline echocardiogram. Patients will be excluded if the baseline echocardiogram is abnormal.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Hector Villarraga, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available