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

Sponsor
University of California, San Diego (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT03553654
Collaborator
(none)
50
Enrollment
1
Location
1
Arm
53
Anticipated Duration (Months)
0.9
Patients Per Site Per Month

Study Details

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
  • Diagnostic Test: low dose CT
 N/A

Study Design

Study Type:
Interventional
Anticipated 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 :
Jan 9, 2018
Anticipated Primary Completion Date :
Jan 9, 2022
Anticipated Study Completion Date :
Jun 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 [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 [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 [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 [12 months after completion of chemotherapy]

    left ventricular ejection fraction change between baseline and post-chemotherapy.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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)

  1. 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

Site City State Country Postal Code
1 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Anna Narezkina, Assistant Professor, University of California, San Diego
ClinicalTrials.gov Identifier:
NCT03553654
Other Study ID Numbers:
  • 160252
First Posted:
Jun 12, 2018
Last Update Posted:
Sep 28, 2021
Last Verified:
Sep 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
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

Study Results

No Results Posted as of Sep 28, 2021