Ignite Creation Date:
2024-05-06 @ 9:32 AM
Last Modification Date:
2024-10-26 @ 12:15 PM
Study NCT ID:
NCT03000036
Status:
COMPLETED
Last Update Posted:
2016-12-21
First Post:
2016-11-28
Brief Title:
Doxorubicin-associated Cardiac Remodeling Followed by CMR in Breast Cancer Patients
Sponsor:
University of Campinas Brazil
Organization:
University of Campinas Brazil
Study Overview
Official Title:
Doxorubicin-associated Cardiac Tissue Remodeling Followed by CMR of Myocardial Extracellular Volume and Myocyte Size in Breast Cancer Patients
Status:
COMPLETED
Status Verified Date:
2016-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Twenty-seven breast cancer women without heart failure underwent CMR imaging 3T-Achieva Philips before and 3 times serially after 4-cycles of adjuvant DOX 60mgm2 CMR assessed left ventricular LV ejection fraction EF T1 mapping pre and post gadolinium and late gadolinium enhancement imaging Biomarkers were obtained before and 72 hours after each DOX-cycle
Detailed Description:
This prospective cohort study was performed at the State University of Campinas Brazil The Institutional Review Board of the State University of Campinas approved the study and all participants provided informed consent Female patients with breast cancer who received anthracycline doxorubicin or daunorubicin or epirubicin as part of their chemotherapy protocol were enrolled in the study
Detailed medical history standard anthropometric data and measurement hemogram troponin CKMB cholesterol serum glucose CRP and biomarkers were obtained
As in adults chronic anthracycline-related cardiotoxicity typically presents early within one year after termination of chemotherapy and the peak time for the appearance of symptoms of heart failure is about three months after the last anthracycline dose patients underwent CMR before and three times serially after DOX two five and twelve months
Patients were imaged in supine position in a 3T magnet Achieva Philips Medical Systems Best The Netherlands The CMR protocol consisted of electrocardiographically gated cine imaging with steady state free-precession to assess left ventricular LV function and LV mass For imaging of late gadolinium enhancement LGE we used an inversion-recovery-prepared gradient-echo sequence with segmented acquisition which was triggered every other heartbeat LGE images were acquired during end-expiratory breath-holding for slices matching the slice locations for cine imaging starting within 10 min after bolus administration of a cumulative dose of 02 mmolKg of gadoterate meglumine Dotarem Guerbet Aulnay-sous-Bois France T1 was performed with a Look-Locker sequence with a non-slice-selective adiabatic inversion pulse followed by segmented gradient-echo acquisition for 17 times after inversion covering approximately two cardiac cycles The Look-Locker sequence was performed in a single short-axis slice at the level of the mid left ventricle T1 imaging was repeated in the same LV short-axis slice once before and five to seven times after the injection of gadolinium to cover an approximately 30-min period of slow contrast clearance
All images were analyzed with MASS CMR software Mass Research Leiden University Medical Center Leiden the Netherlands For LV mass and function quantification the endocardial and epicardial borders of the LV myocardium were manually traced on short-axis cine images at end-diastole and systole Papillary muscles were excluded from LV mass and LV mass was indexed to body surface area
For each Look-Locker image series the endocardial and epicardial borders of the LV were traced and divided into six standard segments Signal intensity versus time curves for each segment and the blood pool were used to determine segmental T1 by nonlinear least-squares fitting to an analytic expression for the magnitude signal measured during the inversion recovery T1 was calculated from the T1 and the amplitude parameters to correct for the effects of radiofrequency pulses applied during the inversion recovery
Pairs of R1 values for myocardial tissue and blood data were fit with a two-space water-exchange model of equilibrium transcytolemmal water exchange The myocardial extracellular volume fraction ECV and the intracellular lifetime of water τic a cell size-dependent parameter were adjustable parameters of this model The measured blood hematocrit was a fixed parameter of the model All R1 measurements for each patient were used to fit the model to determine ECV and τic
Detailed medical history standard anthropometric data and measurement hemogram troponin CKMB cholesterol serum glucose CRP and biomarkers were obtained
As in adults chronic anthracycline-related cardiotoxicity typically presents early within one year after termination of chemotherapy and the peak time for the appearance of symptoms of heart failure is about three months after the last anthracycline dose patients underwent CMR before and three times serially after DOX two five and twelve months
Patients were imaged in supine position in a 3T magnet Achieva Philips Medical Systems Best The Netherlands The CMR protocol consisted of electrocardiographically gated cine imaging with steady state free-precession to assess left ventricular LV function and LV mass For imaging of late gadolinium enhancement LGE we used an inversion-recovery-prepared gradient-echo sequence with segmented acquisition which was triggered every other heartbeat LGE images were acquired during end-expiratory breath-holding for slices matching the slice locations for cine imaging starting within 10 min after bolus administration of a cumulative dose of 02 mmolKg of gadoterate meglumine Dotarem Guerbet Aulnay-sous-Bois France T1 was performed with a Look-Locker sequence with a non-slice-selective adiabatic inversion pulse followed by segmented gradient-echo acquisition for 17 times after inversion covering approximately two cardiac cycles The Look-Locker sequence was performed in a single short-axis slice at the level of the mid left ventricle T1 imaging was repeated in the same LV short-axis slice once before and five to seven times after the injection of gadolinium to cover an approximately 30-min period of slow contrast clearance
All images were analyzed with MASS CMR software Mass Research Leiden University Medical Center Leiden the Netherlands For LV mass and function quantification the endocardial and epicardial borders of the LV myocardium were manually traced on short-axis cine images at end-diastole and systole Papillary muscles were excluded from LV mass and LV mass was indexed to body surface area
For each Look-Locker image series the endocardial and epicardial borders of the LV were traced and divided into six standard segments Signal intensity versus time curves for each segment and the blood pool were used to determine segmental T1 by nonlinear least-squares fitting to an analytic expression for the magnitude signal measured during the inversion recovery T1 was calculated from the T1 and the amplitude parameters to correct for the effects of radiofrequency pulses applied during the inversion recovery
Pairs of R1 values for myocardial tissue and blood data were fit with a two-space water-exchange model of equilibrium transcytolemmal water exchange The myocardial extracellular volume fraction ECV and the intracellular lifetime of water τic a cell size-dependent parameter were adjustable parameters of this model The measured blood hematocrit was a fixed parameter of the model All R1 measurements for each patient were used to fit the model to determine ECV and τic
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None