Early Detection of Imaging-derived Subclinical Cardiac Injuries After Radiotherapy and Chemotherapy for Breast Cancer

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Observational
SUMMARY

Breast cancer (BC) radiotherapy leads to incidental cardiac irradiation, resulting in an increased risk of various major cardiac events (MCEs). In addition, recent studies indicate that for the treatment of BC, the addition of chemotherapy further enhances the risk of MCEs. Information regarding morphological and functional early subclinical cardiac injuries (ESCIs) induced by chemotherapy and radiotherapy that develop into MCEs is largely lacking in scientific literature. This information is essential towards the development of primary and secondary preventive strategies. The EMIRA prospective cohort has as main objective to identify morphological and functional ESCIs in BC patients treated with adjuvant radiotherapy and chemotherapy.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 40
Maximum Age: 70
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Netherlands
UMCG
RECRUITING
Groningen
Contact Information
Primary
Anne Crijns, MD, PhD
a.p.g.crijns@umcg.nl
+31503616161
Time Frame
Start Date: 2019-01-24
Estimated Completion Date: 2024-09-02
Participants
Target number of participants: 148
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: University Medical Center Groningen
Collaborators: Utrecht University

This content was sourced from clinicaltrials.gov