The Study of Breast MRI Screening and Proton Magnetic Resonance Spectroscopy

Not Applicable

Completed

• Conditions: Breast Diseases
• Interventions: Procedure: proton magnetic resonance spectroscopy

• Registration Number: NCT01749748
• Lead Sponsor: National Taiwan University Hospital

Brief Summary

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

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

Study Timeline

• Study Start: 2008-07
• Study First Submitted: 2012-11-17
• Study First Submitted QC: 2012-12-12
• Study First Posted: 2012-12-17
• Primary Completion: 2015-08
• Status Verified: 2016-02
• Study Completion: 2016-02
• Last Update Submitted: 2016-02-01
• Last Update Posted: 2016-02-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 270

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
proton magnetic resonance spectroscopy	proton magnetic resonance spectroscopy	proton magnetic resonance spectroscopy for asymptomatic women breasts.

Primary Outcome Measures

Name	Time	Method
comparison of lipid water composition and ratio of the normal breasts in women of high risk group and low risk group.	up to 5 years ( July 2008 to June 2013)	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan