Ignite Creation Date:
2024-05-06 @ 8:10 AM
Last Modification Date:
2024-10-26 @ 11:57 AM
Study NCT ID:
NCT02688166
Status:
TERMINATED
Last Update Posted:
2022-10-13
First Post:
2016-02-12
Brief Title:
Cardiac MRI Biomarker Testing GCC 1618
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
Cardiac Magnetic Resonance Imaging and Biomarker Testing for Evaluating Cardiac Injury Resulting From Radiation Therapy in Cancer A Pilot Study
Status:
TERMINATED
Status Verified Date:
2022-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Unable to meet accrual goal
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This research study can help understand how cardiac changes may occur with radiation therapy to the heart based off measurements obtained through biomarkers and cardiac imaging
Researchers plan to perform cardiac imaging and biomarkers for any cardiac injury Cardiac magnetic resonance imaging CMR provides the ability to quantitatively measure cardiac function and injury The cardiac biomarkers that will be tested are effective in the diagnosis risk-stratification and monitoring of heart failure
Researchers plan to perform cardiac imaging and biomarkers for any cardiac injury Cardiac magnetic resonance imaging CMR provides the ability to quantitatively measure cardiac function and injury The cardiac biomarkers that will be tested are effective in the diagnosis risk-stratification and monitoring of heart failure
Detailed Description:
The goal is to assess the validity of CMR and biomarker examinations before and after radiotherapy for lung cancer thymic cancer mesothelioma and breast cancers will demonstrate evidence of cardiac strain and dysfunction proportional to the extent of cardiac exposure during the course of radiation The investigators intention is to conduct a pilot study of 10 patients receiving moderate doses of radiation exposure to the heart 5 lung cancer patients thymic cancer or mesothelioma and 5 breast cancer patients when treated by our current institutional standards with the idea that this could lead to a grant if early signs of cardiac injury can be measured These patients treatment plans would include contours to measure dose received by multiple structures within the heart coronary vessels and all cardiac chambers as well as the heartpericardium itself The investigators would obtain biomarkers by bloodwork before during and after radiotherapy for correlation with clinical outcomes and Cardiac MRIs obtained prior to and 1 year after completion of radiotherapy Investigators would obtain biomarkers by bloodwork before during and after radiotherapy for correlation with clinical outcomes and Cardiac MRs obtained prior to and 1 year after completion of radiotherapy
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None