Multifunctional Magnetic Resonance Imaging in Predicting Breast Lesions in Women Undergoing Mastectomy for Breast Cancer
Primary Purpose
Breast Cancer
Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
gadolinium-chelate
conventional surgery
magnetic resonance imaging
magnetic resonance spectroscopic imaging
Sponsored by
About this trial
This is an interventional diagnostic trial for Breast Cancer focused on measuring invasive ductal breast carcinoma, stage IA breast cancer, stage IB breast cancer, stage II breast cancer, stage IIIA breast cancer
Eligibility 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
Sites / Locations
- Royal Marsden - SurreyRecruiting
Outcomes
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
Full Information
NCT ID
NCT00602316
First Posted
January 16, 2008
Last Updated
August 23, 2013
Sponsor
Royal Marsden NHS Foundation Trust
1. Study Identification
Unique Protocol Identification Number
NCT00602316
Brief Title
Multifunctional Magnetic Resonance Imaging in Predicting Breast Lesions in Women Undergoing Mastectomy for Breast Cancer
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 Type
Interventional
2. Study Status
Record Verification Date
June 2009
Overall Recruitment Status
Unknown status
Study Start Date
November 2007 (undefined)
Primary Completion Date
September 2009 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Royal Marsden NHS Foundation Trust
4. Oversight
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
invasive ductal breast carcinoma, stage IA breast cancer, stage IB breast cancer, stage II breast cancer, stage IIIA breast cancer
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
gadolinium-chelate
Intervention Type
Procedure
Intervention Name(s)
conventional surgery
Intervention Type
Procedure
Intervention Name(s)
magnetic resonance imaging
Intervention Type
Procedure
Intervention Name(s)
magnetic resonance spectroscopic imaging
Primary Outcome Measure Information:
Title
Sensitivity of magnetic resonance (MR) techniques in detecting histopathologically-identified multifocal and multicentric lesions
Secondary Outcome Measure Information:
Title
Closeness of agreement between MR techniques and histopathology in localizing satellite lesions relative to the index tumor
Title
Assessment of distribution of satellite lesions in relation to index tumor
Title
Correlation between histopathological characteristics and signal changes on multifunctional MR
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anna Kirby
Organizational Affiliation
Royal Marsden NHS Foundation Trust
Facility Information:
Facility Name
Royal Marsden - Surrey
City
Sutton
State/Province
England
ZIP/Postal Code
SM2 5PT
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Contact Person
Phone
44-208-661-3392
Email
annakirby@doctors.org.uk
12. IPD Sharing Statement
Learn more about this trial
Multifunctional Magnetic Resonance Imaging in Predicting Breast Lesions in Women Undergoing Mastectomy for Breast Cancer
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