Ignite Creation Date:
2024-05-06 @ 2:58 PM
Last Modification Date:
2024-10-26 @ 1:41 PM
Study NCT ID:
NCT04486573
Status:
COMPLETED
Last Update Posted:
2024-03-27
First Post:
2020-07-10
Brief Title:
Cardiac Effects From Radiation Therapy by MRI
Sponsor:
University of Colorado Denver
Organization:
University of Colorado Denver
Study Overview
Official Title:
Identification of Early Cardiac Injury From Radiation Therapy Using Cardiac Magnetic Resonance Imaging
Status:
COMPLETED
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The investigators will identify 10 patients in the department of radiation oncology who will receive standard of-care radiation therapy and the treating radiation oncologist anticipates a mean left ventricular dose of at least 5 Gy Patients will be evaluated by CMRI before and within one week of the completion of RT We will compare the pre- and post-RT CMRI scans to identify changes related to radiation exposure Our primary endpoint will be changes in myocardial strain Secondary endpoints will include other CMRI parameters
Detailed Description:
Cardiac toxicity is a significant cause of morbidity and mortality in cancer survivors after radiation therapy RT to the chest Typically cardiotoxicity is identified years after radiation exposure Emerging clinical data show that subclinical injury can be identified immediately after treatment Early identification of subclinical injury may enable intervention to reduce the risk of progression to clinically significant toxicity The investigators hypothesize that cardiac magnetic resonance imaging CMRI will detect early cardiac injury after RT and that imaging changes will be associated regionally with cardiac radiation dose
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2020-06349 | OTHER | CTRP | None |