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

NCT00602316 | Unknown

• 2 other identifiers: CDR0000581176RMH-CCR2995
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (3)

• 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

Interventions

gadolinium-chelate DRUG

conventional surgery PROCEDURE

magnetic resonance imaging PROCEDURE

magnetic resonance spectroscopic imaging PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Royal Marsden NHS Foundation Trust: lead

Study Sites (1)

Royal Marsden - Surrey

Sutton, England, SM2 5PT, United Kingdom

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms; Carcinoma, Ductal, Breast

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Carcinoma, Ductal; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms, Ductal, Lobular, and Medullary

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Anna Kirby

  Royal Marsden NHS Foundation Trust

Study Design

• Study Type: interventional
• Phase: not applicable
• Purpose: DIAGNOSTIC
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 16, 2008
• First Posted: January 28, 2008
• Study Start: November 1, 2007
• Primary Completion: September 1, 2009
• Last Updated: August 26, 2013

Record last verified: 2009-06

Locations

GB (1)