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Clinical Trials/NCT00462696
NCT00462696
Completed
Not Applicable

Study Evaluating the Contribution of MRI for the Evaluation of Early Response to Neoadjuvant Chemotherapy in Patients With Infiltrative Breast Cancer

Institut Bergonié1 site in 1 country16 target enrollmentFebruary 1, 2006

Overview

Phase
Not Applicable
Intervention
Neoadjuvant chemotherapy
Conditions
Breast Cancer
Sponsor
Institut Bergonié
Enrollment
16
Locations
1
Primary Endpoint
Reproducibility of the MRI Vascular Permeability (Kep)
Status
Completed
Last Updated
6 months ago

Overview

Brief Summary

RATIONALE: Diagnostic procedures, such as magnetic resonance imaging (MRI), may help in learning how well chemotherapy works to kill breast cancer cells and allow doctors to plan better treatment. Drugs used in chemotherapy, such as epirubicin and docetaxel, may stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.

PURPOSE: This clinical trial is studying MRI in evaluating early response to chemotherapy in women receiving chemotherapy for infiltrating breast cancer.

Detailed Description

Pilot study (feasibility) without direct individual benefit aimed at breast cancer patients treated with neoadjuvant chemotherapy prior to local breast surgery (lumpectomy or mastectomy).

Registry
clinicaltrials.gov
Start Date
February 1, 2006
End Date
December 31, 2008
Last Updated
6 months ago
Study Type
Interventional
Study Design
Single Group
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Arms & Interventions

Woment treated with neoadjuvant chemotherapy for breast cancer

The patient will be recruited during a multidisciplinary team meeting (MDT) involving a medical oncologist, radiation oncologist, and surgeon. The histological diagnosis of invasive breast cancer will be confirmed based on the results of the micro-biopsy, which will be performed during the MDT meeting, after the initial MRI scan. The patient will submit her signed informed consent form. The MRI will be performed before the micro-biopsy so as not to distort the measurement of the tumor volume by a possible post-collection hematoma.

Intervention: Neoadjuvant chemotherapy

Outcomes

Primary Outcomes

Reproducibility of the MRI Vascular Permeability (Kep)

Time Frame: two months after start of neoadjuvant chemotherapy

MRI vascular permeability is measured using Kep index (Rate constant between extracellular extravascular space (EES) and plasma). Kep index will be measured at the second cycle of neoadjuvant chemotherapy. MRI will be read independently by two radiologists experienced in breast imaging and breast MRI, blind to the results found by the other, in order to assess the reproducibility of the measurement.

Reproducibility of the MRI Vascular Permeability (HA)

Time Frame: two months after start of neoadjuvant chemotherapy

MRI vascular permeability is measured using HA index (Hepatic Artery index or Hepatic Arterial perfusion). HA index will be measured at the second cycle of neoadjuvant chemotherapy. MRI will be read independently by two radiologists experienced in breast imaging and breast MRI, blind to the results found by the other, in order to assess the reproducibility of the measurement.

Study Sites (1)

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