MRI in Predicting Early Response to Chemotherapy in Patients With Locally Advanced Breast Cancer

Study Overview
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Brief Summary
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RATIONALE: Diagnostic procedures such as MRI scans may help predict early response to treatment in patients with breast cancer undergoing chemotherapy. PURPOSE: This phase II trial is studying MRI in predicting early response to chemotherapy in patients with locally advanced breast cancer.

Detailed Description
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OBJECTIVES: To determine the technical feasibility of using MRI in a multicenter setting using the most commonly available magnetic resonance (MR) systems (i.e., is the trial able to scan patients to a specific protocol, using different types of MRI machine) measured by the number of MRI scans not completed to technical specifications (i.e., incorrect sequences or incomplete scans) or trial protocol (i.e., scans not completed or completed at the wrong time). To determine how reliably the imaging data can be analyzed in a centralized, semi-automated manner (i.e., can MRI data be reliably transferred from different centers and analyzed using software based in the center for MR investigations at the University of Hull) measured by the number of cases where automated data analysis of completed MRI scans was not possible (i.e., data could not be analyzed at all or data required manual analysis). OUTLINE: This is a multicenter study. Patients undergo magnetic resonance imaging (MRI) scans at baseline, 4-7 days after beginning after the first course of chemotherapy, at the end of their second course of chemotherapy, and at the end of their fourth course of chemotherapy (first regimen). MRI techniques may include dynamic contrast-enhanced, diffusion-weighted, and spectroscopic.

Official Title
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Neo Comice Pilot; Efficacy of Advanced Semi-automated Functional Magnetic Resonance (MR) Imaging in the Early Prediction of Response of Locally Advanced Breast Cancer to Neoadjuvant Chemotherapy

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: systemic chemotherapy
* Procedure: diffusion-weighted magnetic resonance imaging
* Procedure: dynamic contrast-enhanced magnetic resonance imaging
* Procedure: magnetic resonance spectroscopic imaging
* Procedure: neoadjuvant therapy


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Newly diagnosed, histologically proven breast cancer Stage T2-4B, N0-3C, and M0 disease Locally advanced primary disease Underwent both x-ray mammography and breast ultrasound scanning during the current treatment episode Scheduled for neoadjuvant chemotherapy PATIENT CHARACTERISTICS: Not pregnant or nursing Medically stable No renal failure No serious breast trauma within the past 3 months No known allergic reaction associated with previous administration of a paramagnetic contrast agent No known contraindication to magnetic resonance (MR) scanning Must pass the normal safety requirements of MR, particularly pacemakers and cardiac defibrillators No disability preventing MR scanning in the prone position No body habitus incompatible with MR system entry PRIOR CONCURRENT THERAPY: See Disease Characteristics No prior chemotherapy No prior surgery or radiotherapy for cancer in the ipsilateral breast More than 4 months since prior surgery to the ipsilateral breast for benign breast disease

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: systemic chemotherapy|nan|
|Procedure: diffusion-weighted magnetic resonance imaging|nan|
|Procedure: dynamic contrast-enhanced magnetic resonance imaging|nan|
|Procedure: magnetic resonance spectroscopic imaging|nan|
|Procedure: neoadjuvant therapy|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Failed scan rate (i.e., the number of scans that failed protocol) grouped by cause, including patient refusal, protocol violation in timing, major errors in scan protocols, and minor errors in scan protocol |  |  | 
| Failed automated MRI-scan data-analysis rate (i.e., number of scans that required manual reading and number of protocol-compliant scans that were unreadable, subdivided according to whether the scans were technically compliant or not) |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer