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Sponsored by: |
University of Calgary |
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Information provided by: | University of Calgary |
ClinicalTrials.gov Identifier: | NCT00679874 |
Consecutive patients with a first diagnosis of breast cancer will be identified at the Tom Baker Cancer Centre (TBCC) and included into the study, if they are going to receive chemotherapy with anthracyclines and / or Trastuzumab and do not have contra-indications for the CMR study. Besides the usual clinical care for these patients (e.g. blood samples before each cycle of chemotherapy; MUGA scans to follow cardiac size and function), the patients will undergo serial contrast-enhanced CMR studies (before, during and 9-12 months after completion of the chemotherapy); patients will be seen at an outpatient clinic in the Dept. of Cardiac Sciences / Heart Function Clinic for a clinical assessment (including ECG, additional blood test like Troponin-T, BNP, 6-minute-walk-test) and recommendations will be made to medical treatment in patients with evidence for heart failure.
Time points for the CMR and clinic assessments will be co-coordinated with regularly scheduled test by the TBCC to avoid unnecessary burden for the patients. The oncologists at the TBCC will be blinded to the results of the CMR studies and to laboratory results, unless the participating cardiologists identify a clinical need for communication.
Standardized CMR protocols will be employed and all interpretations will be blinded to the time course of the chemotherapy and cardiotoxic side effects.
We will test the hypothesis, whether CMR can be useful in patients with potentially cardiotoxic chemotherapy to:
Condition | Intervention |
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Breast Cancer |
Other: Cardio-vascular MRI |
Study Type: | Observational |
Study Design: | Cohort, Prospective |
Official Title: | Characterization of the Cardiotoxic Effects of Chemotherapies With Anthracyclines and Trastuzumab for Breast Cancer by Contrast-Enhanced Cardiovascular Magnetic Resonance Imaging (CMR). |
Estimated Enrollment: | 66 |
Study Start Date: | May 2008 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
Groups/Cohorts | Assigned Interventions |
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Consecutive patients with first-time diagnosis of metastatic breast cancer undergoing chemotherapy with anthracyclines and/or trastuzumab.
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Other: Cardio-vascular MRI
Contrast enhanced CMR studies at baseline, in the middle of chemotherapy and as follow-up
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Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
Consecutive patients with a first diagnosis of breast cancer will be identified at the Tom Baker Cancer Centre (TBCC) and included into the study, if they are going to receive chemotherapy with anthracyclines and / or Trastuzumab and do not have contra-indications for the CMR study.
Inclusion Criteria:
Exclusion Criteria:
Canada, Alberta | |
University of Calgary, Dept. of Cardiac Sciences and Tom Baker Cancer Centre | |
Calgary, Alberta, Canada, T2N 2T9 |
Principal Investigator: | Oliver Strohm, MD, FESC | University of Calgary |
Responsible Party: | University of Calgary ( Oliver Strohm, MD, FESC. Associate Professor, Departments. of Cardiac Sciences and Radiology, University of Calgary ) |
Study ID Numbers: | Cardiotox_001 |
Study First Received: | May 15, 2008 |
Last Updated: | May 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00679874 |
Health Authority: | Canada: Ethics Review Committee |
Cardiovascular Magnetic Resonance Imaging Cardiotoxicity Anthracyclines |
Trastuzumab Breast cancer Toxicity |
Skin Diseases Trastuzumab Breast Neoplasms Breast Diseases |
Neoplasms Neoplasms by Site |