Low-dose CT-based Method for Detection of Subclinical Anthracycline-induced Cardiotoxicity
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03553654|
Recruitment Status : Active, not recruiting
First Posted : June 12, 2018
Last Update Posted : September 28, 2021
|Condition or disease||Intervention/treatment||Phase|
|Neoplasms||Diagnostic Test: low dose CT||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Low-dose CT-based Method for Detection of Subclinical Anthracycline-induced Cardiotoxicity|
|Actual Study Start Date :||January 9, 2018|
|Estimated Primary Completion Date :||January 9, 2022|
|Estimated Study Completion Date :||June 9, 2022|
Experimental: CT monitoring arm
18-75 year old patients with newly-diagnosed cancer, scheduled to undergo anthracycline-based chemotherapy.
Diagnostic Test: low dose CT
CT-based protocol for detection of anthracycline-induced myocardial dysfunction at early stages
- cardiomyopathy [ Time Frame: 12 months after completion of chemotherapy ]Cardiomyopathy is defined as a decrease in the left ventricular ejection fraction by echocardiography of greater than 10 percentage points, to a value < 53% (normal reference value for 2D echocardiography).
- Change in CT-based left ventricular strain parameters [ Time Frame: 12 months after completion of chemotherapy ]Change in CT-based left ventricular strain parameters before and after the chemotherapy
- Change in left ventricular global longitudinal strain based on echocardiography [ Time Frame: 12 months after completion of chemotherapy ]Change in left ventricular global longitudinal strain between baseline and post-chemotherapy.
- Change in echocardiographic left ventricular ejection fraction [ Time Frame: 12 months after completion of chemotherapy ]left ventricular ejection fraction change between baseline and post-chemotherapy.
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): NCT03553654
|United States, California|
|University of California San Diego Medical Center|
|San Diego, California, United States, 92037|
|Principal Investigator:||Anna Narezkina, MD||UCSD|