The Study of Breast MRI Screening and Proton Magnetic Resonance Spectroscopy

February 1, 2016 updated by: National Taiwan University Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

270

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei, Taiwan, 100
        • National Taiwan University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: 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 Names:
  • proton MRS

What is the study measuring?

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.
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.
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
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.
up to 5 years (July 2008 to June 2013)
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.
up to 5 years ( July 2008 to June 2013)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2008

Primary Completion (ACTUAL)

August 1, 2015

Study Completion (ACTUAL)

February 1, 2016

Study Registration Dates

First Submitted

November 17, 2012

First Submitted That Met QC Criteria

December 12, 2012

First Posted (ESTIMATE)

December 17, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

February 2, 2016

Last Update Submitted That Met QC Criteria

February 1, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 200806009R

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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