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

Royal Marsden NHS Foundation Trust

Status: Unknown

Conditions: Breast Cancer

Treatments: Drug: gadolinium-chelate; Procedure: magnetic resonance spectroscopic imaging; Procedure: magnetic resonance imaging; Procedure: conventional surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT00602316

CDR0000581176

RMH-CCR2995

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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