Early Detection of Cardiac Toxicity of Trastuzumab (Herceptin ®) in Patients Treated for Breast Carcinoma: Value of Magnetic Resonance Imaging

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-29

Study Completion Date

2017-05-31

Brief Summary

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The main objective of this study is to compare the proportions of late enhancement in patients with Left ventricular (LV) dysfunction as Herceptin ® and in a control group consisting of patients who did not have LV dysfunction after 6 months under the same treatment.

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Detailed Description

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Conditions

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Cancer, Breast LV Dysfunction

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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LV dysfunction group

Cardiac MRI

Group Type OTHER

Cardiac MRI

Intervention Type OTHER

The examinations will be conducted on an MRI with a dedicated antenna heart, by a physician with expertise in cardiac MRI.

After establishing a good quality ECG synchronization, the following sequences are carried out successively:

* Sequences locating anatomical
* T2 black blood (such as ESF)
* rapid sequence of cine-MRI (such as balanced FFE) vertical and horizontal long axis and short axis of the base to the apex
* T1-weighted sequence with inversion recovery for the assessment of possible consequences of cell damage.

Control group

Cardiac MRI

Group Type OTHER

Cardiac MRI

Intervention Type OTHER

The examinations will be conducted on an MRI with a dedicated antenna heart, by a physician with expertise in cardiac MRI.

After establishing a good quality ECG synchronization, the following sequences are carried out successively:

* Sequences locating anatomical
* T2 black blood (such as ESF)
* rapid sequence of cine-MRI (such as balanced FFE) vertical and horizontal long axis and short axis of the base to the apex
* T1-weighted sequence with inversion recovery for the assessment of possible consequences of cell damage.

Interventions

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Cardiac MRI

The examinations will be conducted on an MRI with a dedicated antenna heart, by a physician with expertise in cardiac MRI.

After establishing a good quality ECG synchronization, the following sequences are carried out successively:

* Sequences locating anatomical
* T2 black blood (such as ESF)
* rapid sequence of cine-MRI (such as balanced FFE) vertical and horizontal long axis and short axis of the base to the apex
* T1-weighted sequence with inversion recovery for the assessment of possible consequences of cell damage.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Women over 18 years
* Free and informed consent signed
* Histologically confirmed adenocarcinoma of the breast, metastatic or non-metastatic
* LVEF\> 50% angioscintigraphy before the start of treatment with Herceptin ®,
* Overexpression of HER2 in the invasive component of the primary tumor (3 + 2 + according to ICH or with confirmation of positivity by FISH or CISH)
* Patient receiving treatment with Herceptin ®,
* Inclusion in the control group: patients treated with Herceptin ® episode without LV dysfunction,
* For the inclusion in the Group LV dysfunction: the appearance of a decrease in LVEF during treatment with Herceptin ®, angioscintigraphy identified.

Exclusion Criteria

* Heart disease or serious medical conditions do not allow to administer Herceptin ® (documented history of heart failure, angina requiring treatment, severe dyspnoea at rest or oxygen dependency),
* History of ischemic heart disease or myocarditis
* Known allergy to trastuzumab, murine proteins or any of the excipients
* Patients with an indication against the MRI (claustrophobia, ferromagnetic foreign body, pacemaker or implantable defibrillator, known allergy to gadolinium salts)
* Renal impairment (creatinine clearance \<60 ml / min according to the MDRD formula)
* Arrhythmia atrial fibrillation,
* Contraindications to the administration of Dotarem ®,
* Patient unable to give informed consent,
* Adult Trust,
* Pregnant or lactating
* Patient unable to undergo a medical for geographical, social or psychological.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No