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The Study of Breast MRI Screening and Proton Magnetic Resonance Spectroscopy

This study is currently recruiting participants.
Verified December 2012 by National Taiwan University Hospital
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT01749748
First received: November 17, 2012
Last updated: December 12, 2012
Last verified: December 2012
History of Changes
  Purpose

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.


Condition Intervention
Breast Diseases
 Procedure: proton magnetic resonance spectroscopy

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: The Study of Breast MRI Screening and Proton Magnetic Resonance Spectroscopy

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
    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:
  • 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) ] [ Designated as safety issue: No ]
    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 [ 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.


Estimated Enrollment: 270
Study Start Date: July 2008
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
proton magnetic resonance spectroscopy
proton magnetic resonance spectroscopy for asymptomatic women breasts.
 Procedure: proton magnetic resonance spectroscopy
proton magnetic resonance spectroscopy was performed for the normal breast to evaluate the chemical composition of breast
Other Name: proton MRS

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   25 Years to 75 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Women without breast symptoms
  • 25-75 years old.
  • Negative mammography result in recent 6 months

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01749748

Contacts
Contact: Jane Wang, MD 886-2-23123456 ext 65565 hstjen@yahoo.com.tw

Locations
Taiwan
National Taiwan University Hospital Recruiting
Taipei, Taiwan, 100
Contact: Jane Wang, MD     886-2-23123456 ext 65565     hstjen@yahoo.com.tw    
Principal Investigator: Jane Wang, MD            
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Principal Investigator: Jane Wang, PhD National Taiwan University Hospital
  More Information

No publications provided

Responsible Party: National Taiwan University Hospital, physician, clinical assistant professor, principal investigator of Department of Medical Imaging
ClinicalTrials.gov Identifier: NCT01749748     History of Changes
Other Study ID Numbers: 200806009R
Study First Received: November 17, 2012
Last Updated: December 12, 2012
Health Authority: Taiwan: Department of Health

Keywords provided by National Taiwan University Hospital:
Breast diseases
magnetic resonance spectroscopy

Additional relevant MeSH terms:
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on June 17, 2013