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

August 23, 2013 updated by: Royal Marsden NHS Foundation Trust

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Royal Marsden NHS Foundation Trust

Investigators

  • Anna Kirby, Royal Marsden NHS Foundation Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2007

Primary Completion (Anticipated)

September 1, 2009

Study Registration Dates

First Submitted

January 16, 2008

First Submitted That Met QC Criteria

January 16, 2008

First Posted (Estimate)

January 28, 2008

Study Record Updates

Last Update Posted (Estimate)

August 26, 2013

Last Update Submitted That Met QC Criteria

August 23, 2013

Last Verified

June 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000581176
  • RMH-CCR2995

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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