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Completed

NCT Number: NCT01749748

The Study of Breast MRI Screening and Proton Magnetic Resonance Spectroscopy

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.

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Key information

Conditions

Breast Diseases Skin Diseases Skin and Connective Tissue Diseases

Age range

25 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

National Taiwan University Hospital

Taipei, 100, Taiwan

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

proton magnetic resonance spectroscopy

Procedure

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

Other names: proton MRS

Primary outcomes

  1. comparison of lipid water composition and ratio of the normal breasts in women of high risk group and low risk group.

    Time frame: 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 outcomes

  1. to investigate the association between breast density and lipid water ratio of normal breasts

    Time frame: 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.

  2. to investigate the association between menopausal status and lipid water ratio of normal breasts

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Important dates

Study start
2008
Primary completion
2015
Study completion
2016
First posted
Dec 17, 2012
Registry last updated
Feb 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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