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The Study of Breast MRI Screening and Proton Magnetic Resonance Spectroscopy

The Study of Breast MRI Screening and Proton Magnetic Resonance Spectroscopy

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01749748
Enrollment
270
Registered
2012-12-17
Start date
2008-07-31
Completion date
2016-02-29
Last updated
2016-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Diseases

Keywords

Breast diseases, magnetic resonance spectroscopy

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.

Interventions

proton magnetic resonance spectroscopy was performed for the normal breast to evaluate the chemical composition of breast

Sponsors

National Taiwan University Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
25 Years to 75 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
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

MeasureTime frameDescription
to investigate the association between breast density and lipid water ratio of normal breastsup 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 breastsup 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.

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026