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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 : June 14, 2019
Sponsor:
Information provided by (Responsible Party):
Anna Narezkina, University of California, San Diego

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
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, 2021
Estimated Study Completion Date : June 9, 2021

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




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.



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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
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.

Information from the National Library of Medicine

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


Contacts
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Contact: Anna Narezkina, MD 8586578530 anarezkina@ucsd.edu

Locations
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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   
Sponsors and Collaborators
University of California, San Diego
Investigators
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Principal Investigator: Anna Narezkina, MD UCSD

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Responsible Party: Anna Narezkina, Assistant Professor, University of California, San Diego
ClinicalTrials.gov Identifier: NCT03553654     History of Changes
Other Study ID Numbers: 160252
First Posted: June 12, 2018    Key Record Dates
Last Update Posted: June 14, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cardiotoxicity
Pathologic Processes
Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders
Radiation Injuries
Wounds and Injuries