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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00602316
• Other study ID #: CDR0000581176
• Secondary ID: RMH-CCR2995
• Status: Recruiting
• Phase: N/A
• First received: January 16, 2008
• Last updated: August 23, 2013
• Start date: November 2007

Study information

• Verified date: June 2009
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Unspecified
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

DISEASE CHARACTERISTICS:

• Biopsy-confirmed invasive ductal carcinoma of the breast

• Unifocal disease as defined by clinical examination, mammography, and ultrasound

• Patient must be proceeding to mastectomy

• Hormone receptor status unknown

• No T4d or multifocal disease (as defined on conventional imaging)

• Index tumor = 4 cm in diameter

PATIENT CHARACTERISTICS:

• Menopausal status not specified

• Female

• No claustrophobia

• No cup size of DD or greater

PRIOR CONCURRENT THERAPY:

• No prior surgery to ipsilateral breast

• No prior neoadjuvant chemotherapy

• No prior ferromagnetic implants

Study Design

Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• gadolinium-chelate

Procedure:
• conventional surgery

• magnetic resonance imaging

• magnetic resonance spectroscopic imaging

Locations

Country	Name	City	State
United Kingdom	Royal Marsden - Surrey	Sutton	England

Sponsors (1)

Lead Sponsor	Collaborator
Royal Marsden NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity of magnetic resonance (MR) techniques in detecting histopathologically-identified multifocal and multicentric lesions			No
Secondary	Closeness of agreement between MR techniques and histopathology in localizing satellite lesions relative to the index tumor			No
Secondary	Assessment of distribution of satellite lesions in relation to index tumor			No
Secondary	Correlation between histopathological characteristics and signal changes on multifunctional MR			No