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Trial Title:
Multifunctional Magnetic Resonance Imaging in Predicting Breast Lesions in Women Undergoing Mastectomy for Breast Cancer
NCT ID:
NCT00602316
Condition:
Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Chelating Agents
Conditions: Keywords:
invasive ductal breast carcinoma
stage IA breast cancer
stage IB breast cancer
stage II breast cancer
stage IIIA breast cancer
Study type:
Interventional
Study phase:
N/A
Overall status:
Unknown status
Study design:
Primary purpose:
Diagnostic
Intervention:
Intervention type:
Drug
Intervention name:
gadolinium-chelate
Intervention type:
Procedure
Intervention name:
conventional surgery
Intervention type:
Procedure
Intervention name:
magnetic resonance imaging
Intervention type:
Procedure
Intervention name:
magnetic resonance spectroscopic imaging
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.
Criteria for 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
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Royal Marsden - Surrey
Address:
City:
Sutton
Zip:
SM2 5PT
Country:
United Kingdom
Status:
Recruiting
Contact:
Last name:
Contact Person
Phone:
44-208-661-3392
Email:
annakirby@doctors.org.uk
Start date:
November 2007
Lead sponsor:
Agency:
Royal Marsden NHS Foundation Trust
Agency class:
Other
Source:
National Cancer Institute (NCI)
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT00602316
