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

• ClinicalTrials.gov Identifier: NCT03553654
• Recruitment Status: Active, not recruiting
• First Posted: June 12, 2018
• Last Update Posted: September 28, 2021
• Sponsor: University of California, San Diego
• Information provided by (Responsible Party): Anna Narezkina, University of California, San Diego

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Neoplasms	Diagnostic Test: low dose CT	Not Applicable

Study Design

• 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

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

1. 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).

Secondary Outcome Measures :

1. 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
2. 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.
3. 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Locations

United States, California

University of California San Diego Medical Center

San Diego, California, United States, 92037

Sponsors and Collaborators

University of California, San Diego

Investigators

• Principal Investigator: Anna Narezkina, MD; UCSD

More Information

• 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
• Last Update Posted: September 28, 2021
• Last Verified: September 2021

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

Additional relevant MeSH terms:

Cardiotoxicity; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders; Radiation Injuries; Wounds and Injuries