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OpenTrials
Completed

NCT Number: NCT03553654

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

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.

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Key information

Conditions

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California San Diego Medical Center

San Diego, California, 92037, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:
  • 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.

Treatment and study plan

Low dose CT

Diagnostic Test

CT-based protocol for detection of anthracycline-induced myocardial dysfunction at early stages

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of California, San Diego

Other

Registry information

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Jun 12, 2018
Registry last updated
Nov 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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