The Study of Breast MRI Screening and Proton Magnetic Resonance Spectroscopy

Breast Diseases Clinical Trial

Official title:

The Study of Breast MRI Screening and Proton Magnetic Resonance Spectroscopy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01749748
• Other study ID #: 200806009R
• Status: Completed
• Phase: N/A
• First received: November 17, 2012
• Last updated: February 1, 2016
• Start date: July 2008
• Est. completion date: February 2016

Study information

• Verified date: February 2016
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 270
• Est. completion date: February 2016
• Est. primary completion date: August 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 25 Years to 75 Years

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Breast Diseases

Intervention

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

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	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.	up to 5 years (July 2008 to June 2013)	No
Secondary	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.	up to 5 years ( July 2008 to June 2013)	No