Breast CancerNCT02666378
Imaging Markers of Subclinical Cardiotoxicity in Breast Cancer
An observational study of Breast Cancer, run by Beth Israel Deaconess Medical Center at 1 site in United States.
Trial summary
This research study is evaluating the use of Cardiac Magnetic Resonance Imaging (CMR) as a method of detecting early signs of damage to the heart that can be associated with anthracycline-based chemotherapy for the treatment of breast cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Cardiac Magnetic Resonance Imaging (CMR) and Echocardiogram (ECHO)
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Sep 2018to 10 Jul 2024
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Breast Cancer
Who may be able to join
- Age > 18 years
- Have histologic diagnosis of breast carcinoma
- Scheduled to receive standard clinical therapy designed by their treating oncologist
- Patients should receive anthracycline as part of the recommended treatment
- Able to give informed consent.
Who cannot join
- Contraindication to contrast CMR including eGFR <30 mls/min/1.73m2
- Uncontrolled serious concurrent illness
- Pregnancy or breast feeding
Trial locations and contacts
1 site in 1 country.
United States1 site
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02115
About this study
This research study is evaluating the use of Cardiac Magnetic Resonance Imaging (CMR) as a method of detecting early signs of damage to the heart that can be associated with anthracycline-based chemotherapy for the treatment of breast cancer.
Read the detailed description
One of the side effects observed in breast cancer patients receiving anthracycline-based treatment is heart complications in which the heart muscle is weakened and no longer able to pump sufficient amounts of blood throughout the body. This complication can lead to the following symptoms: shortness of breath on exertion, swollen ankles and feet, lack of energy and a reduced capacity to carry out day-to-day activities.
This research study is focused on identifying the early signs of such heart complications using CMR, which may allow preventative treatment options to be made available in future.
- Conditions
- Breast Cancer
- Being tested
- Cardiac Magnetic Resonance Imaging (CMR), Echocardiogram (ECHO)
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac Magnetic Resonance Imaging (CMR)Other
Also called MRI
Subjects will be recruited for observational cardiac magnetic resonance imaging.
Echocardiogram (ECHO)Other
Subjects will undergo a research echocardiogram if a clinical echocardiogram has not already been ordered.
| Study group | Role | What they receive |
|---|---|---|
| CMR/ECHO | Prior to starting chemotherapy treatment, the participant will undergo the following procedures:
* Cardiac Magnetic Resonance Imaging (CMR)
* Echocardiogram (ECHO) in patients with no clinically indicated scans
* Each imaging procedure will be repeated at predetermined times during the protocol
* Simple blood collection for plasma biomarker analysis Receives: Other: Cardiac Magnetic Resonance Imaging (CMR); Other: Echocardiogram (ECHO) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiotoxicity
Cardiotoxicity as measured by changes in left ventricular ejection fraction within one-year of completion of treatment
Measured: 1 year after completion of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2016 (estimated)
- Study start10 Sep 2018
- Primary completion10 Jul 2024
- Study completion10 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Beth Israel Deaconess Medical CenterThe 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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- American Heart Association, Dana-Farber Cancer Institute
- Responsible party
- Principal investigator, Reza Nezafat, Beth Israel Deaconess Medical Center
- Investigators
- Reza Nezafat, Ph.D, Principal investigator, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02666378
- Sponsor's protocol ID
- 15-017
- Status last verified
- Jul 2023
- First submitted
- 16 Nov 2015
- Last updated
- 1 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Imaging Markers of Subclinical Cardiotoxicity in Breast Cancer
- ClinicalTrials.gov ID
- NCT02666378
- Acronym / sponsor ID
- 15-017
- Conditions
- Breast Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Collaborators
- American Heart Association, Dana-Farber Cancer Institute
- Study start
- 10 Sep 2018 (actual)
- Primary completion
- 10 Jul 2024 (actual)
- Study completion
- 10 Jul 2024 (actual)
- First posted
- 28 Jan 2016 (estimated)
- 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.
This research study is evaluating the use of Cardiac Magnetic Resonance Imaging (CMR) as a method of detecting early signs of damage to the heart that can be associated with anthracycline-based chemotherapy for the treatment of breast cancer.
Detailed description
One of the side effects observed in breast cancer patients receiving anthracycline-based treatment is heart complications in which the heart muscle is weakened and no longer able to pump sufficient amounts of blood throughout the body. This complication can lead to the following symptoms: shortness of breath on exertion, swollen ankles and feet, lack of energy and a reduced capacity to carry out day-to-day activities.
This research study is focused on identifying the early signs of such heart complications using CMR, which may allow preventative treatment options to be made available in future.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CMR/ECHO | – | Other: Cardiac Magnetic Resonance Imaging (CMR), Other: Echocardiogram (ECHO)Prior to starting chemotherapy treatment, the participant will undergo the following procedures: * Cardiac Magnetic Resonance Imaging (CMR) * Echocardiogram (ECHO) in patients with no clinically indicated scans * Each imaging procedure will be repeated at predetermined times during the protocol * Simple blood collection for plasma biomarker analysis |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Breast Cancer
Key inclusion criteria (5 listed)
- Age > 18 years
- Have histologic diagnosis of breast carcinoma
- Scheduled to receive standard clinical therapy designed by their treating oncologist
- Patients should receive anthracycline as part of the recommended treatment
- Able to give informed consent.
Key exclusion criteria (3 listed)
- Contraindication to contrast CMR including eGFR <30 mls/min/1.73m2
- Uncontrolled serious concurrent illness
- Pregnancy or breast feeding
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 Imaging (CMR)Also: MRISubjects will be recruited for observational cardiac magnetic resonance imaging. | Other | CMR/ECHO |
| Echocardiogram (ECHO)Subjects will undergo a research echocardiogram if a clinical echocardiogram has not already been ordered. | Other | CMR/ECHO |
Primary outcome
Cardiotoxicity
Time frame: 1 year after completion of treatment
Cardiotoxicity as measured by changes in left ventricular ejection fraction within one-year of completion of treatment
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 1 Oct 2024.
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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.
Reza Nezafat, Ph.D principal investigator
Beth Israel Deaconess Medical Center
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 Breast Cancer, run by Beth Israel Deaconess Medical Center 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 5 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: finished, as of the sponsor's last update on 1 Oct 2024. 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?
Cardiotoxicity (time frame: 1 year after completion of treatment). 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 1 Oct 2024.