The Study of Breast MRI Screening and Proton Magnetic Resonance Spectroscopy

Study Overview
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Brief Summary
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To delineate if the chemical composition (lipid and water) in the presumably normal breast of the high risk women is different from those of the low risk group.

Detailed Description
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The researchers would like to investigate and compare the chemical composition in the normal breast between high risk women and general population.

Official Title
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The Study of Breast MRI Screening and Proton Magnetic Resonance Spectroscopy

Conditions
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Breast Diseases

Intervention / Treatment
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* Procedure: proton magnetic resonance spectroscopy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women without breast symptoms (without family history of breast cancer; or with at least first-degree relative of breast cancer) with negative mammography and ultrasound result in recent 3 months or contralateral normal breasts from women with newly diagnosed unilateral breast cancer 25-75 years old. Exclusion Criteria: renal function impairment past history of anaphylactoid reaction to MRI contrast media (Gd-DTPA) pregnant or lactating women medication of HRT or oral pills in recent 6 months past history of surgery of the breast (either side) past history of breast cancer with breast implant or silicone injection past history of cardiac surgery, mechanical valve replacement, aneurismal clip, endotracheal tube or tracheostomy tube, any metallic implants.

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: proton magnetic resonance spectroscopy<br>proton magnetic resonance spectroscopy for asymptomatic women breasts. | Procedure: proton magnetic resonance spectroscopy<br>* proton magnetic resonance spectroscopy was performed for the normal breast to evaluate the chemical composition of breast<br>* Other names: proton MRS;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| comparison of lipid water composition and ratio of the normal breasts in women of high risk group and low risk group. | This is a cross sectional study. And we just assess the chemical composition of normal breasts of women at a given time point, since the participants only received one time of study. | up to 5 years ( July 2008 to June 2013) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| to investigate the association between breast density and lipid water ratio of normal breasts | to investigate whether there is association of breast density and chemical composition of normal breast on proton magnetic resonance spectroscopy. | up to 5 years (July 2008 to June 2013) | 
| to investigate the association between menopausal status and lipid water ratio of normal breasts | to investigate whether there is association of menopausal status and chemical composition of normal breast on proton magnetic resonance spectroscopy. | up to 5 years ( July 2008 to June 2013) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast diseases, magnetic resonance spectroscopy