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

NCT01956513 | Withdrawn

• 1 other identifier: Etude ADC
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Assess the Variation of Apparent Diffusion Coefficient

Keywords

ADC; breast cancer; complete pathological response

Outcome Measures

Primary Outcomes (1)

• 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

  One year

Interventions

MRI (Magnetic resonance imaging) OTHER

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.

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Centre Jean Perrin: lead

MeSH Terms

Conditions

Breast Neoplasms; Pathologic Complete Response

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Disease Progression; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Anne BAILLY, MD

  Centre Jean Perrin

  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: SPONSOR

Study Record Dates

• First Submitted: March 16, 2012
• First Posted: October 8, 2013
• Study Start: March 1, 2012
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2013
• Last Updated: October 8, 2013

Record last verified: 2013-10