NCT00602316

Multifunctional Magnetic Resonance Imaging in Predicting Breast Lesions in Women Undergoing Mastectomy for Breast Cancer

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Royal Marsden NHS Foundation Trust · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	gadolinium-chelate
PROCEDURE	conventional surgery
PROCEDURE	magnetic resonance imaging
PROCEDURE	magnetic resonance spectroscopic imaging

Timeline

• Start date: 2007-11-01
• Primary completion: 2009-09-01
• First posted: 2008-01-28
• Last updated: 2013-08-26

Locations

1 site across 1 country: United Kingdom