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Clinical Trials/NCT00602316
NCT00602316
Unknown
Not Applicable

Using Magnetic Resonance Techniques to Improve the Characterisation and Localisation of Breast Cancer. A Pilot Observational Study Testing the Accuracy of Multifunctional Magnetic Resonance Techniques in Predicting the Presence, Distribution and Nature of Breast Lesions in Women With Known Breast Cancer

Royal Marsden NHS Foundation Trust1 site in 1 country20 target enrollmentNovember 2007

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Breast Cancer
Sponsor
Royal Marsden NHS Foundation Trust
Enrollment
20
Locations
1
Primary Endpoint
Sensitivity of magnetic resonance (MR) techniques in detecting histopathologically-identified multifocal and multicentric lesions
Last Updated
12 years ago

Overview

Brief Summary

RATIONALE: Diagnostic procedures, such as multifunctional magnetic resonance imaging, may help doctors learn the extent of disease and plan the best treatment.

PURPOSE: This clinical trial is studying how well multifunctional magnetic resonance imaging works in predicting breast lesions in women undergoing mastectomy for breast cancer.

Detailed Description

OBJECTIVES: * To determine the accuracy of multifunctional magnetic resonance (MR) in detecting, localizing, and characterizing satellite lesions in relation to an index breast tumor in order to improve definition of clinical target volume after local excision. OUTLINE: Patients receive an injection of gadolinium chelate and undergo multifunctional magnetic resonance (MR) imaging, including dynamic contrast-enhanced MR, hydrogen-MR spectroscopy, and diffusion-weighted MRI, of the ipsilateral breast within 4 weeks before surgery. Patients undergo a mastectomy as planned. The resected specimen is photographed, and a histopathological analysis is performed consisting of the size and grade (if pre-invasive or invasive disease) of each satellite lesion, classification of benign satellite lesions, dimensions of each lesion, distance from the edge of the index tumor to the center of each satellite lesion, and the distance from the center of the surface of the nipple to the center of each lesion.

Registry
clinicaltrials.gov
Start Date
November 2007
End Date
September 2009
Last Updated
12 years ago
Study Type
Interventional
Sex
Female

Investigators

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Sensitivity of magnetic resonance (MR) techniques in detecting histopathologically-identified multifocal and multicentric lesions

Secondary Outcomes

  • Closeness of agreement between MR techniques and histopathology in localizing satellite lesions relative to the index tumor
  • Assessment of distribution of satellite lesions in relation to index tumor
  • Correlation between histopathological characteristics and signal changes on multifunctional MR

Study Sites (1)

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