Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Prospective single arm study to evaluate a low-dose CT-based protocol for early detection of myocardial dysfunction in 50 cancer patients undergoing anthracycline-based chemotherapy.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CT monitoring arm | Experimental | 18-75 year old patients with newly-diagnosed cancer, scheduled to undergo anthracycline-based chemotherapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| low dose CT | Diagnostic Test | CT-based protocol for detection of anthracycline-induced myocardial dysfunction at early stages |
|
| Measure | Description | Time Frame |
|---|---|---|
| cardiomyopathy | 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). | 12 months after completion of chemotherapy |
| Measure | Description | Time Frame |
|---|---|---|
| Change in CT-based left ventricular strain parameters | Change in CT-based left ventricular strain parameters before and after the chemotherapy | 12 months after completion of chemotherapy |
| Change in left ventricular global longitudinal strain based on echocardiography |
Not provided
Inclusion Criteria:
Ability to understand and the willingness to sign a written informed consent.
18-75 year old patients with newly-diagnosed cancer scheduled to undergo anthracycline-based chemotherapy (minimum of 200 mg/m2 of doxorubicin or equivalent) at UCSD Medical Center.
Women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
• A woman of child-bearing potential is any female (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:
Women of child-bearing potential must have a negative pregnancy test during the screening period.
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Anna Narezkina, MD | UCSD | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California San Diego Medical Center | San Diego | California | 92037 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D009369 | Neoplasms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Change in left ventricular global longitudinal strain between baseline and post-chemotherapy. |
| 12 months after completion of chemotherapy |
| Change in echocardiographic left ventricular ejection fraction | left ventricular ejection fraction change between baseline and post-chemotherapy. | 12 months after completion of chemotherapy |