Low-dose CT-based Method for Detection of Subclinical Anthracycline-induced Cardiotoxicity
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ClinicalTrials.gov Identifier: NCT03553654 |
Recruitment Status :
Recruiting
First Posted : June 12, 2018
Last Update Posted : July 15, 2020
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Condition or disease | Intervention/treatment | Phase |
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Neoplasms | Diagnostic Test: low dose CT | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 50 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Diagnostic |
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 |
Arm | Intervention/treatment |
---|---|
Experimental: CT monitoring arm
18-75 year old patients with newly-diagnosed cancer, scheduled to undergo anthracycline-based chemotherapy.
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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.

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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.
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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:
- Has not undergone a hysterectomy or bilateral oophorectomy; or
- Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months)
- Women of child-bearing potential must have a negative pregnancy test during the screening period.
Exclusion Criteria:
- Prior chemotherapy with anthracycline;
- Persistent tachycardia (heart rate>90);
- LVEF<53% or history of cardiomyopathy or decompensated heart failure;
- Baseline GLS below lower limit of normal (normal range varies depending on age and gender (23)) or inability to obtain meaningful strain data due to poor quality of Echocardiographic images;
- Known unrevascularized coronary artery disease, myocardial infarction within 30 days of enrollment;
- Moderate or severe valvular heart disease;
- Prior allergy or intolerance to iodinated contrast;
- Renal failure (GFR<30, creatinine >1.5);
- Cancer involvement of the heart.

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
Contact: Anna Narezkina, MD | 8586578530 | anarezkina@ucsd.edu |
United States, California | |
University of California San Diego Medical Center | Recruiting |
San Diego, California, United States, 92037 | |
Contact: Anna Narezkina, MD 858-657-8530 anarezkina@ucsd.edu |
Principal Investigator: | Anna Narezkina, MD | UCSD |
Responsible Party: | Anna Narezkina, Assistant Professor, University of California, San Diego |
ClinicalTrials.gov Identifier: | NCT03553654 |
Other Study ID Numbers: |
160252 |
First Posted: | June 12, 2018 Key Record Dates |
Last Update Posted: | July 15, 2020 |
Last Verified: | July 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Cardiotoxicity Pathologic Processes Drug-Related Side Effects and Adverse Reactions |
Chemically-Induced Disorders Radiation Injuries Wounds and Injuries |