- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03575650
Early Detection of Imaging-derived Subclinical Cardiac Injuries (EMIRA)
Early Detection of Imaging-derived Subclinical Cardiac Injuries After Radiotherapy and Chemotherapy for Breast Cancer
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
EMIRA is a single centre prospective observational cohort study performed in the UMCG. The study includes breast cancer patients that underwent primary surgery, either by mastectomy or breast conserving surgery, who are treated with adjuvant radiotherapy and chemotherapy as part of routine clinical care. The patient follow up time continues for 2 years after radiotherapy to identify early subclinical cardiac injuries (ESCIs), using repeat echocardiography (cECHO), cardiac MRI (cMRI) scans and cardiac CT (cCT) scans. The images are acquired prior to chemotherapy and/or radiotherapy (depending on the sequence of adjuvant treatment), and at 6 and 24 months after radiotherapy The first primary aim of this project is to detect ESCIs that are considered risk factors for clinically apparent major cardiac events in breast cancer patients treated with radiotherapy and chemotherapy. The second is to use this information to develop prediction models describing the relationship between the radiation dose to cardiac substructures and ESCIs.
In detail, the investigators aim to:
- identify longitudinal morphological and functional ESCIs using echocardiography, cardiac MRI and cardiac CT before and after BC treatment;
- determine the relationship between 3D-dose distributions to cardiac substructures and ESCI;
- establish the effect of chemotherapy on the dose-effect relationship between radiation dose and ESCI.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Anne Crijns, MD, PhD
- Phone Number: +31503616161
- Email: a.p.g.crijns@umcg.nl
Study Locations
-
-
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Groningen, Netherlands, 9713GZ
- Recruiting
- UMCG
-
Contact:
- Anne Crijns, MD PhD
- Phone Number: +31-652724432
- Email: a.p.g.crijns@umcg.nl
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Female unilateral BC patients
- Primary breast conserving surgery or mastectomy for stage I-III invasive adenocarcinoma of the breast or ductal carcinoma in situ (DCIS)
- Age between 40-70 years at time of chemotherapy/radiotherapy
- WHO performance status 0-1
- Planned radiotherapy to the breast/chest wall with or without the lymph node areas
- Radiotherapy based on planning CT-scan, using either 3D CRT, (partial) IMRT or (partial) VMAT/RapidArc with or without deep inspiration breath-hold
- Adjuvant systemic chemotherapy (before or after radiotherapy)
- Written informed consent
Exclusion Criteria:
- Male BC patients
- M1 disease (metastatic BC)
- Previous thoracic or mediastinal radiation
- Neo-adjuvant chemotherapy not allowed
- Targeted HER2 therapy not allowed
- Medical history of coronary artery disease and/or myocardial infarction and/or atrial fibrillation
- Contraindications to injection of iodinated contrast such as allergy or renal failure
- Pregnancy or lactation
- Atrial fibrillation detected during electrocardiogram before chemotherapy/radiotherapy
- Abnormal echocardiography before chemotherapy/radiotherapy defined as: LVEF <50%, longitudinal strain <-16%, longitudinal strain rate <-1%, and/or abnormal wall motion
- Presence of myocardial infarction detected during cMRI before chemotherapy/radiotherapy
- cMRI or cCT results before chemotherapy/radiotherapy requiring revascularisation
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Cardiac imaging modalities
Repeat echocardiography (cECHO), cardiac MRI (cMRI) scans and cardiac CT (cCT) scans will be performed to evaluate myocardial dysfunction and deformation; myocardium inclusing tissue abnormalities, cardiac morphology and function and; coronary artery lesions and coronary artery calcium score.
|
Repeat cardiac echocardiographies, MRI-scans and CT-scans for early subclinical biomarker assessments in breast cancer patients treated with chemotherapy and radiotherapy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Left Ventricle Global Longitudinal Strain (LV-GLS) assessed by echocardiography
Time Frame: 6 and 24 months after radiotherapy with reference to baseline
|
Increasement in left ventricle Global Longitudinal Strain (GLS) of at least 5%
|
6 and 24 months after radiotherapy with reference to baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in myocardial function assessed by echocardiography
Time Frame: 6 and 24 after completion of radiotherapy with reference to baseline
|
Increasement of segmental strain measurements (unit of measures:%)
|
6 and 24 after completion of radiotherapy with reference to baseline
|
Anatomical changes in coronary arteries by cardiac CT
Time Frame: 6 and 24 after completion of radiotherapy with reference to baseline
|
Increase in the number of coronary segments containing any plaque/stenosis, or increase in calcium score
|
6 and 24 after completion of radiotherapy with reference to baseline
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Myocardial tissue abnormalities assessed by cardiac MRI
Time Frame: 6 and 24 after completion of radiotherapy with reference to baseline
|
Increase of the native mean myocardial T1 mapping value assessed by cardiac MRI
|
6 and 24 after completion of radiotherapy with reference to baseline
|
Collaborators and Investigators
Collaborators
Investigators
- Study Chair: Hans Langendijk, Prof.Dr, UMCG
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2018-06
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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