NeoplasmsNCT03553654
Low-dose CT-based Method for Detection of Subclinical Anthracycline-induced Cardiotoxicity
A study testing low dose CT in people with Neoplasms, run by University of California, San Diego at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Neoplasms
- What is being tested?
- low dose CT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jan 2018to 12 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- Prior allergy or intolerance to iodinated contrast;
- Renal failure (GFR<30, creatinine >1.5);
- Cancer involvement of the heart.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California San Diego Medical Center
San Diego, California, 92037
About this study
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.
- Conditions
- Neoplasms
- Being tested
- low dose CT
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
low dose CTDiagnostic test
CT-based protocol for detection of anthracycline-induced myocardial dysfunction at early stages
| Study group | Role | What they receive |
|---|---|---|
| CT monitoring arm | Experimental | 18-75 year old patients with newly-diagnosed cancer, scheduled to undergo anthracycline-based chemotherapy. Receives: Diagnostic Test: low dose CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 12 months after completion of chemotherapy
Secondary outcomes (3)
Change in CT-based left ventricular strain parameters
Change in CT-based left ventricular strain parameters before and after the chemotherapy
Measured: 12 months after completion of chemotherapy
Change in left ventricular global longitudinal strain based on echocardiography
Change in left ventricular global longitudinal strain between baseline and post-chemotherapy.
Measured: 12 months after completion of chemotherapy
Change in echocardiographic left ventricular ejection fraction
left ventricular ejection fraction change between baseline and post-chemotherapy.
Measured: 12 months after completion of chemotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2018
- Study start9 Jan 2018
- Primary completion12 Dec 2021
- Study completion12 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeoplasmsStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anna Narezkina, University of California, San Diego
- Investigators
- Anna Narezkina, MD, Principal investigator, UCSD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03553654
- Sponsor's protocol ID
- 160252
- Status last verified
- Nov 2022
- First submitted
- 24 Jan 2018
- Last updated
- 3 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low-dose CT-based Method for Detection of Subclinical Anthracycline-induced Cardiotoxicity
- ClinicalTrials.gov ID
- NCT03553654
- Acronym / sponsor ID
- 160252
- Conditions
- Neoplasms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Study start
- 9 Jan 2018 (actual)
- Primary completion
- 12 Dec 2021 (actual)
- Study completion
- 12 Dec 2021 (actual)
- First posted
- 12 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CT monitoring arm | Experimental | Diagnostic Test: low dose CT18-75 year old patients with newly-diagnosed cancer, scheduled to undergo anthracycline-based chemotherapy. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
- Women of child-bearing potential must have a negative pregnancy test during the screening period.
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| low dose CTCT-based protocol for detection of anthracycline-induced myocardial dysfunction at early stages | Diagnostic test | CT monitoring arm |
Primary outcome
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).
3 secondary outcomes
Change in CT-based left ventricular strain parameters
Time frame: 12 months after completion of chemotherapy
Change in left ventricular global longitudinal strain based on echocardiography
Time frame: 12 months after completion of chemotherapy
Change in echocardiographic left ventricular ejection fraction
Time frame: 12 months after completion of chemotherapy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anna Narezkina, MD principal investigator
UCSD
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing low dose CT in people with Neoplasms, run by University of California, San Diego at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cardiomyopathy (time frame: 12 months after completion of chemotherapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2022; AzTrials last refreshed its copy on 6 Nov 2026.