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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

ClinicalTrials.gov Identifier: NCT00602316

Recruitment Status : Unknown

Verified June 2009 by National Cancer Institute (NCI).
Recruitment status was: Recruiting

First Posted : January 28, 2008

Last Update Posted : August 26, 2013

Sponsor:

Information provided by:

National Cancer Institute (NCI)

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Breast Cancer	Drug: gadolinium-chelate Procedure: conventional surgery Procedure: magnetic resonance imaging Procedure: magnetic resonance spectroscopic imaging	Not Applicable

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.

Study Design


Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	20 participants
Primary Purpose:	Diagnostic
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
Study Start Date :	November 2007
Estimated Primary Completion Date :	September 2009

Resource links provided by the National Library of Medicine

Genetics Home Reference related topics: Breast cancer

MedlinePlus related topics: Breast Cancer MRI Scans Mastectomy

U.S. FDA Resources

Arms and Interventions

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

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

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00602316

Locations


United Kingdom
Royal Marsden - Surrey	Recruiting
Sutton, England, United Kingdom, SM2 5PT
Contact: Contact Person 44-208-661-3392 annakirby@doctors.org.uk

Sponsors and Collaborators

Royal Marsden NHS Foundation Trust

Investigators


OverallOfficial:	Anna Kirby	Royal Marsden NHS Foundation Trust

More Information


ClinicalTrials.gov Identifier:	NCT00602316 History of Changes
Other Study ID Numbers:	CDR0000581176 RMH-CCR2995
First Posted:	January 28, 2008 Key Record Dates
Last Update Posted:	August 26, 2013
Last Verified:	June 2009

Keywords provided by National Cancer Institute (NCI):


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

Additional relevant MeSH terms:


Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases

To Top