Low-dose CT-based Method for Detection of Subclinical Anthracycline-induced Cardiotoxicity

Neoplasms Clinical Trial

Official title:

Low-dose CT-based Method for Detection of Subclinical Anthracycline-induced Cardiotoxicity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03553654
• Other study ID #: 160252
• Status: Completed
• Phase: N/A
• Start date: January 9, 2018
• Est. completion date: December 12, 2021

Study information

• Verified date: November 2022
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: December 12, 2021
• Est. primary completion date: December 12, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Ability to understand and the willingness to sign a written informed consent.

2. 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.

3. 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)

4. Women of child-bearing potential must have a negative pregnancy test during the screening period.

Exclusion Criteria:

1. Prior chemotherapy with anthracycline;

2. Persistent tachycardia (heart rate>90);

3. LVEF<53% or history of cardiomyopathy or decompensated heart failure;

4. 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;

5. Known unrevascularized coronary artery disease, myocardial infarction within 30 days of enrollment;

6. Moderate or severe valvular heart disease;

7. Prior allergy or intolerance to iodinated contrast;

8. Renal failure (GFR<30, creatinine >1.5);

9. Cancer involvement of the heart.

Related Conditions & MeSH terms

• Cardiotoxicity
• Neoplasms

Intervention

Diagnostic Test:
• low dose CT
CT-based protocol for detection of anthracycline-induced myocardial dysfunction at early stages

Locations

Country	Name	City	State
United States	University of California San Diego Medical Center	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Diego

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	Change in left ventricular global longitudinal strain based on echocardiography	Change in left ventricular global longitudinal strain between baseline and post-chemotherapy.	12 months after completion of chemotherapy
Secondary	Change in echocardiographic left ventricular ejection fraction	left ventricular ejection fraction change between baseline and post-chemotherapy.	12 months after completion of chemotherapy