Back to resultsThe Study of Breast MRI Screening and Proton Magnetic Resonance Spectroscopy
Primary Purpose
Breast Diseases
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
proton magnetic resonance spectroscopy
Sponsored by
About this trial
This is an interventional basic science trial for Breast Diseases focused on measuring Breast diseases, magnetic resonance spectroscopy
Eligibility Criteria
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.
Sites / Locations
- National Taiwan University Hospital
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
proton magnetic resonance spectroscopy
Arm Description
proton magnetic resonance spectroscopy for asymptomatic women breasts.
Outcomes
Primary Outcome Measures
comparison of lipid water composition and ratio of the normal breasts in women of high risk group and low risk group.
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
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
to investigate whether there is association of menopausal status and chemical composition of normal breast on proton magnetic resonance spectroscopy.
Full Information
NCT ID
NCT01749748
First Posted
November 17, 2012
Last Updated
February 1, 2016
Sponsor
National Taiwan University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01749748
Brief Title
The Study of Breast MRI Screening and Proton Magnetic Resonance Spectroscopy
Official Title
The Study of Breast MRI Screening and Proton Magnetic Resonance Spectroscopy
Study Type
Interventional
2. Study Status
Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
July 2008 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
February 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Taiwan University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Diseases
Keywords
Breast diseases, magnetic resonance spectroscopy
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
270 (Actual)
8. Arms, Groups, and Interventions
Arm Title
proton magnetic resonance spectroscopy
Arm Type
Other
Arm Description
proton magnetic resonance spectroscopy for asymptomatic women breasts.
Intervention Type
Procedure
Intervention Name(s)
proton magnetic resonance spectroscopy
Other Intervention Name(s)
proton MRS
Intervention Description
proton magnetic resonance spectroscopy was performed for the normal breast to evaluate the chemical composition of breast
Primary Outcome Measure Information:
Title
comparison of lipid water composition and ratio of the normal breasts in women of high risk group and low risk group.
Description
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.
Time Frame
up to 5 years ( July 2008 to June 2013)
Secondary Outcome Measure Information:
Title
to investigate the association between breast density and lipid water ratio of normal breasts
Description
to investigate whether there is association of breast density and chemical composition of normal breast on proton magnetic resonance spectroscopy.
Time Frame
up to 5 years (July 2008 to June 2013)
Title
to investigate the association between menopausal status and lipid water ratio of normal breasts
Description
to investigate whether there is association of menopausal status and chemical composition of normal breast on proton magnetic resonance spectroscopy.
Time Frame
up to 5 years ( July 2008 to June 2013)
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jane Wang, PhD
Organizational Affiliation
National Taiwan University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
12. IPD Sharing Statement
Learn more about this trial
The Study of Breast MRI Screening and Proton Magnetic Resonance Spectroscopy
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