Contribution of MRI in the Evaluation of Apparent Diffusion Coefficient and Prediction of Response to Neoadjuvant Chemotherapy in Breast Cancer

NCT ID: NCT01956513

Last Updated: 2013-10-08

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

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2013-10-31

Brief Summary

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The main objective of the study is to assess the sensitivity and the specificity of the variation of apparent diffusion coefficient for prediction, after a course of neoadjuvant chemotherapy or after modification of the treatment sequence, the pathological response at the end of chemotherapy

Detailed Description

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Conditions

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Assess the Variation of Apparent Diffusion Coefficient

Keywords

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ADC breast cancer complete pathological response

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Interventions

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MRI (Magnetic resonance imaging)

MRI will be realised at the beginning of the study, after a cycle of chemotherapy or at changement of sequence and at the end of chemotherapy.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Age\> 18 years.
* Patient suffering from a breast tumor, regardless of the stage and size
* Patient requiring neoadjuvant chemotherapy
* Patient has the ability to undergo 18F-FDG-PET at baseline, at end of cycle 1 and at the end of neoadjuvant treatment before surgery
* Compulsory affiliation to a social security system.
* Obtaining informed consent in writing, signed and dated.

Exclusion Criteria

* Patient with cognitive or psychiatric disorders.
* Patient deprived of liberty by a court or administrative.
* Patient with signs against the achievement of MRI, mammography and ultrasound
* Patient metastatic
* Patient with prior chemotherapy, radiotherapy and hormone therapy for her breast cancer
* Pregnant women, current lactation
* Patient suffering from uncontrolled diabetes (\> 11 mmol / L)
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Centre Jean Perrin

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Anne BAILLY, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Jean Perrin

Other Identifiers

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Etude ADC

Identifier Type: -

Identifier Source: org_study_id