The Study of Breast MRI Screening and Proton Magnetic Resonance Spectroscopy
1 other identifier
interventional
270
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2008
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2008
CompletedFirst Submitted
Initial submission to the registry
November 17, 2012
CompletedFirst Posted
Study publicly available on registry
December 17, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2016
CompletedFebruary 2, 2016
February 1, 2016
7.1 years
November 17, 2012
February 1, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
up to 5 years ( July 2008 to June 2013)
Secondary Outcomes (2)
to investigate the association between breast density and lipid water ratio of normal breasts
up to 5 years (July 2008 to June 2013)
to investigate the association between menopausal status and lipid water ratio of normal breasts
up to 5 years ( July 2008 to June 2013)
Study Arms (1)
proton magnetic resonance spectroscopy
OTHERproton magnetic resonance spectroscopy for asymptomatic women breasts.
Interventions
proton magnetic resonance spectroscopy was performed for the normal breast to evaluate the chemical composition of breast
Eligibility Criteria
You may qualify if:
- 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
- years old.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Taiwan University Hospital
Taipei, 100, Taiwan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jane Wang, PhD
National Taiwan University Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- physician, clinical assistant professor, principal investigator of Department of Medical Imaging
Study Record Dates
First Submitted
November 17, 2012
First Posted
December 17, 2012
Study Start
July 1, 2008
Primary Completion
August 1, 2015
Study Completion
February 1, 2016
Last Updated
February 2, 2016
Record last verified: 2016-02