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

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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
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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
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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


Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Sensitivity of magnetic resonance (MR) techniques in detecting histopathologically-identified multifocal and multicentric lesions

Secondary Outcome Measures :
  1. Closeness of agreement between MR techniques and histopathology in localizing satellite lesions relative to the index tumor
  2. Assessment of distribution of satellite lesions in relation to index tumor
  3. Correlation between histopathological characteristics and signal changes on multifunctional MR

Eligibility Criteria
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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
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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
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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
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OverallOfficial: Anna Kirby Royal Marsden NHS Foundation Trust
More Information
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ClinicalTrials.gov Identifier: NCT00602316    
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:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
 Skin Diseases
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action