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

October 7, 2013 updated by: Centre Jean Perrin

Etude ADC Apport de l'IRM Dans l'évaluation du Coefficient de Diffusion Apparent et prédiction de la réponse à la chimiothérapie néoadjuvante Dans le Cancer du Sein

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

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Variation of apparent diffusion coefficient before / after a cycle of neoadjuvant chemotherapy or before / after modification of the treatment sequence and correlated with histologic response
Time Frame: One year
One year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Jean Perrin

Investigators

  • Principal Investigator: Anne BAILLY, MD, Centre Jean Perrin

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (Anticipated)

October 1, 2013

Study Completion (Anticipated)

October 1, 2013

Study Registration Dates

First Submitted

March 16, 2012

First Submitted That Met QC Criteria

October 7, 2013

First Posted (Estimate)

October 8, 2013

Study Record Updates

Last Update Posted (Estimate)

October 8, 2013

Last Update Submitted That Met QC Criteria

October 7, 2013

Last Verified

October 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Etude ADC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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