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

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00602316

Enrollment

Registered

2008-01-28

Start date

2007-11-30

Completion date

Unknown

Last updated

2013-08-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

invasive ductal breast carcinoma, stage IA breast cancer, stage IB breast cancer, stage II breast cancer, stage IIIA breast cancer

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.

Interventions

DRUGgadolinium-chelate

PROCEDUREconventional surgery

PROCEDUREmagnetic resonance imaging

PROCEDUREmagnetic resonance spectroscopic imaging

Study design

Primary purpose

DIAGNOSTIC

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Inclusion 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

Design outcomes

Primary

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

Secondary

Measure	Time frame
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	—

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026