Doxorubicin-associated Cardiac Remodeling Followed by CMR in Breast Cancer Patients

NCT03000036 | Completed

• 1 other identifier: DOX-0675014600011
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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 (60mg/m2). 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.

Conditions

Breast Cancer Female; Doxorubicin Induced Cardiomyopathy

Keywords

Breast cancer; Doxorubicin; Cardiovascular Magnetic Resonance; T1 mapping

Outcome Measures

Primary Outcomes (2)

• Quantification of fibrosis index by Cardiac Magnetic Resonance

  Estimate the extracellular volume fraction derived from gadolinium-DTPA partition Coefficient of the myocardium

  two years

• Intracellular lifetime of water (τic) by Cardiac Magnetic Resonance

  This metric estimates the myocyte size using Cardiac Magnetic Resonance T1 mapping data

  two years

Secondary Outcomes (4)

• Left ventricular mass by Cardiac Magnetic Resonance

  two years

• Left ventricular volumes by Cardiac Magnetic Resonance

  two years

• Left ventricular ejection fraction by Cardiac Magnetic Resonance

  two years

• Left ventricular myocardial edema fraction by Cardiac Magnetic Resonance

  two years

Other Outcomes (1)

• Ultra-sensitive troponin

  two years

Study Arms (1)

Cardiovascular Magnetic Resonance

OTHER

Twenty-seven female patients were imaged in a 3T magnet after consecutively enrolled in the study if they had received a breast cancer diagnosis at the Center for Integral Attention to Women's Health (University of Campinas) and had prescribed endovenous doxorubicin as part of their chemotherapy regimen.

Drug: Doxorubicin; Device: Achieva, Philips Medical Systems (3T magnet); Drug: Gadoterate Meglumine

Interventions

Doxorubicin DRUG

Patients had prescribed endovenous doxorubicin as part of their chemotherapy regimen (mean cumulative dose 102,66 mg/m2, administered in 4 doses with 21 days interval).

Also known as: Adriamycin

Cardiovascular Magnetic Resonance

Achieva, Philips Medical Systems (3T magnet) DEVICE

Patients were imaged in supine position in a 3T magnet (Achieva, Philips Medical Systems, Best, The Netherlands). The protocol consisted of electrocardiographically gated cine imaging with steady state free-precession to assess left ventricular (LV) ejection fraction and LV mass. For imaging of late gadolinium-DTPA 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, after administration of Dotarem. 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. 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.

Also known as: Cardiovascular Magnetic Resonance (CMR)

Cardiovascular Magnetic Resonance

Gadoterate Meglumine DRUG

LGE images were acquired starting within 10 min after bolus administration of a cumulative dose of 0.2 mmol/Kg of gadoterate meglumine (Dotarem, Guerbet, Aulnay-sous-Bois, France).

Also known as: Dotarem

Cardiovascular Magnetic Resonance

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Breast cancer and had prescribed an anthracycline agent as part of their chemotherapy regimen

You may not qualify if:

• Strict contraindications to MRI
• Acute or chronic kidney failure
• Previously diagnosed myocardial infarction, heart failure, valvular disease or cardiomyopathy.

Sponsors & Collaborators

• University of Campinas, Brazil: lead
• Fundação de Amparo à Pesquisa do Estado de São Paulo: collaborator

Study Sites (1)

State University of Campinas

Campinas, São Paulo, 13083-887, Brazil

Location

Related Publications (26)

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  PMID: 30092965 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Doxorubicin; gadoterate meglumine

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates

Study Officials

• Otávio R. Coelho-Filho, MD, MPH, PhD

  University of Campinas, Brazil

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 28, 2016
• First Posted: December 21, 2016
• Study Start: July 1, 2012
• Primary Completion: January 1, 2015
• Study Completion: July 1, 2016
• Last Updated: December 21, 2016

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)