Chemotherapy Induced CardiotoxicityNCT03301389
Cardiac Magnetic Resonance for Early Detection of Chemotherapy or Radiation Therapy Induced Cardiotoxicity in Breast Cancer (CareBest)
An observational study of Chemotherapy Induced Cardiotoxicity, run by Yonsei University at 1 site in South Korea.
Trial summary
Chemotherapy or radiation therapy-induced cardiotoxicity are well-recognized side effects in patients with cancer. The clinical significance of cardiotoxicity is growing with increasing cancer survivor-ship. Read more about this study
- Who is it for?
- Ages 17 to 80 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Chemotherapy Induced Cardiotoxicity
- What is being tested?
- Cardiac magnetic resonance imaging
- How many people
- 2,000 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Dec 2016to Jan 2025
- Phase
- Observational
- 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 17 to 80 years
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: The breast cancer patient with pretreatment state The breast cancer patients with the prior chemotherapy, or radiation therapy The breast cancer patients receiving prior chemotherapy, or radiation therapy The breast cancer patients with other treatments
Who may be able to join
- Patient with breast cancer
Who cannot join
- Contraindication of MRI
- Failure with informed consent
- Fail to scan screening protocol
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Department of Radiology, Research Institute of Radiological Science, Severance Hospital, Yonsei University College of Medicine
Seoul, 03722
Byoung Wook Choi, MD, 82-2228-7400, bchoi@yuhs.ac
About this study
Chemotherapy or radiation therapy-induced cardiotoxicity are well-recognized side effects in patients with cancer. The clinical significance of cardiotoxicity is growing with increasing cancer survivor-ship.
Left ventricular (LV) functional assessment is the standard of reference to diagnose chemotherapy- or radiation therapy-induced cardiotoxicity. The investigators will investigate the usefulness of T1 mapping parameters for early detection and prediction of chemotherapy-, radiation therapy-, or other therapy-induced cardiotoxicity in breast cancer patients This study aimed to achieve early detection of chemotherapy- or radiation therapy-induced cardiotoxicity using T1 mapping magnetic resonance imaging (MRI) and determine a prognostic imaging factor of chemotherapy- or radiation therapy-induced cardiotoxicity in patients treated for breast cancer.
Read the detailed description
Screening and follow-up cardiac magnetic resonance imaging (CMR) protocols for diagnosis of cardiotoxicity will be conducted in patients with breast cancer who have received or are planned to receive treatment for breast cancer. The protocol will include T1 and T2 mapping and cine imaging of the LV myocardium.
- Conditions
- Chemotherapy Induced Cardiotoxicity
- Being tested
- Cardiac magnetic resonance imaging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac magnetic resonance imagingOther
The cardiac imaging protocol will include pre-contrast T1, post-contrast T1, and T2 mapping images acquired of the mid ventricle with the short axis plane for the analysis of native T1, T2, and extracellular volume (ECV) values of the myocardium. It will also include cine imaging covering the whole LV myocardium in the short axis plane for a functional analysis of the LV myocardium.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Not described Receives: Other: Cardiac magnetic resonance imaging | |
| Pretreatment group | Patients in pretreatment state Receives: Other: Cardiac magnetic resonance imaging | |
| Anthracycline-based chemotherapy (3 months) | Patients who received anthracycline-based chemotherapy 3 months ago Receives: Other: Cardiac magnetic resonance imaging | |
| Anthracycline-based chemotherapy (6 months) | Patients who received anthracycline-based chemotherapy 6 months ago Receives: Other: Cardiac magnetic resonance imaging | |
| Anthracycline-based chemotherapy (more than 1 year ago) | Patients who received anthracycline-based chemotherapy more than 1 year ago Receives: Other: Cardiac magnetic resonance imaging | |
| Other therapy group | Patients who have been treated with other therapies (other chemo-therapies, combined radiation therapy, target agent therapy, hormone therapy) Receives: Other: Cardiac magnetic resonance imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decrease in LVEF (left ventricular ejection fraction)
Decrease in LVEF : more than 10% compared to the baseline LVEF) or LVEF < 50%
Measured: 1 year after CMR scanning
Decrease in LVEF (left ventricular ejection fraction)
Decrease in LVEF : more than 10% compared to the baseline LVEF) or LVEF < 50%
Measured: 2 years after CMR scanning
Secondary outcomes (2)
MACE (Major adverse cardiac events)
Measured: 1 year after CMR scanning
MACE (Major adverse cardiac events)
Measured: 2 years after CMR scanning
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2017
- Study start1 Dec 2016
- Primary completionJan 2025 (estimated)
- Study completionJan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chemotherapy Induced CardiotoxicityStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03301389
- Sponsor's protocol ID
- 4-2016-0730
- Status last verified
- Jan 2019
- First submitted
- 29 Sep 2017
- Last updated
- 11 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hong YJ, Han K, Lee HJ, Hur J, Kim YJ, Kim MJ, Choi BW. Assessment of Feasibility and Interscan Variability of Short-time Cardiac MRI for Cardiotoxicity Evaluation in Breast Cancer. Radiol Cardiothorac Imaging. 2024 Feb;6(1):e220229. doi: 10.1148/ryct.220229.
PubMed 38329404Hong YJ, Kim GM, Han K, Kim PK, Lee SA, An E, Lee JY, Lee HJ, Hur J, Kim YJ, Kim MJ, Choi BW. Cardiotoxicity evaluation using magnetic resonance imaging in breast Cancer patients (CareBest): study protocol for a prospective trial. BMC Cardiovasc Disord. 2020 Jun 3;20(1):264. doi: 10.1186/s12872-020-01497-y.
PubMed 32493217
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiac Magnetic Resonance for Early Detection of Chemotherapy or Radiation Therapy Induced Cardiotoxicity in Breast Cancer (CareBest)
- ClinicalTrials.gov ID
- NCT03301389
- Acronym / sponsor ID
- 4-2016-0730
- Conditions
- Chemotherapy Induced Cardiotoxicity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 1 Dec 2016 (actual)
- Primary completion
- Jan 2025 (estimated)
- Study completion
- Jan 2025 (estimated)
- First posted
- 4 Oct 2017 (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.
Chemotherapy or radiation therapy-induced cardiotoxicity are well-recognized side effects in patients with cancer. The clinical significance of cardiotoxicity is growing with increasing cancer survivor-ship.
Left ventricular (LV) functional assessment is the standard of reference to diagnose chemotherapy- or radiation therapy-induced cardiotoxicity. The investigators will investigate the usefulness of T1 mapping parameters for early detection and prediction of chemotherapy-, radiation therapy-, or other therapy-induced cardiotoxicity in breast cancer patients This study aimed to achieve early detection of chemotherapy- or radiation therapy-induced cardiotoxicity using T1 mapping magnetic resonance imaging (MRI) and determine a prognostic imaging factor of chemotherapy- or radiation therapy-induced cardiotoxicity in patients treated for breast cancer.
Detailed description
Screening and follow-up cardiac magnetic resonance imaging (CMR) protocols for diagnosis of cardiotoxicity will be conducted in patients with breast cancer who have received or are planned to receive treatment for breast cancer. The protocol will include T1 and T2 mapping and cine imaging of the LV myocardium.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Control group | – | Other: Cardiac magnetic resonance imaging |
| Pretreatment group | – | Other: Cardiac magnetic resonance imagingPatients in pretreatment state |
| Anthracycline-based chemotherapy (3 months) | – | Other: Cardiac magnetic resonance imagingPatients who received anthracycline-based chemotherapy 3 months ago |
| Anthracycline-based chemotherapy (6 months) | – | Other: Cardiac magnetic resonance imagingPatients who received anthracycline-based chemotherapy 6 months ago |
| Anthracycline-based chemotherapy (more than 1 year ago) | – | Other: Cardiac magnetic resonance imagingPatients who received anthracycline-based chemotherapy more than 1 year ago |
| Other therapy group | – | Other: Cardiac magnetic resonance imagingPatients who have been treated with other therapies (other chemo-therapies, combined radiation therapy, target agent therapy, hormone therapy) |
Who may qualify
- Ages
- 17 to 80 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The breast cancer patient with pretreatment state The breast cancer patients with the prior chemotherapy, or radiation therapy The breast cancer patients receiving prior chemotherapy, or radiation therapy The breast cancer patients with other treatments
Key inclusion criteria (1 listed)
- Patient with breast cancer
Key exclusion criteria (3 listed)
- Contraindication of MRI
- Failure with informed consent
- Fail to scan screening protocol
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 |
|---|---|---|
| Cardiac magnetic resonance imagingThe cardiac imaging protocol will include pre-contrast T1, post-contrast T1, and T2 mapping images acquired of the mid ventricle with the short axis plane for the analysis of native T1, T2, and extracellular volume (ECV) values of the myocardium. It will also include cine imaging covering the whole LV myocardium in the short axis plane for a functional analysis of the LV myocardium. | Other | Anthracycline-based chemotherapy (3 months), Anthracycline-based chemotherapy (6 months), Anthracycline-based chemotherapy (more than 1 year ago), Control group, Other therapy group, Pretreatment group |
Primary outcome
Decrease in LVEF (left ventricular ejection fraction)
Time frame: 1 year after CMR scanning
Decrease in LVEF : more than 10% compared to the baseline LVEF) or LVEF < 50%
Decrease in LVEF (left ventricular ejection fraction)
Time frame: 2 years after CMR scanning
Decrease in LVEF : more than 10% compared to the baseline LVEF) or LVEF < 50%
2 secondary outcomes
MACE (Major adverse cardiac events)
Time frame: 1 year after CMR scanning
MACE (Major adverse cardiac events)
Time frame: 2 years after CMR scanning
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2019.
- Derived from this study: PubMed 38329404Hong YJ, Han K, Lee HJ, Hur J, Kim YJ, Kim MJ, Choi BW. Assessment of Feasibility and Interscan Variability of Short-time Cardiac MRI for Cardiotoxicity Evaluation in Breast Cancer. Radiol Cardiothorac Imaging. 2024 Feb;6(1):e220229. doi: 10.1148/ryct.220229.
- Derived from this study: PubMed 32493217Hong YJ, Kim GM, Han K, Kim PK, Lee SA, An E, Lee JY, Lee HJ, Hur J, Kim YJ, Kim MJ, Choi BW. Cardiotoxicity evaluation using magnetic resonance imaging in breast Cancer patients (CareBest): study protocol for a prospective trial. BMC Cardiovasc Disord. 2020 Jun 3;20(1):264. doi: 10.1186/s12872-020-01497-y.
- 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.
Department of Radiology, Research Institute of Radiological Science, Severance Hospital, Yonsei University College of Medicine
Seoul, South Korea
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chemotherapy Induced Cardiotoxicity, run by Yonsei University at 1 site in South Korea.
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 1 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 11 Jan 2019. 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 South Korea. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decrease in LVEF (left ventricular ejection fraction) (time frame: 1 year after CMR scanning). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03301389, which also lists 2 linked publications.
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 11 Jan 2019.