Breast Density and the Role of Preoperative Mammography, Ultrasound, Elastography and MRI

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ClinicalTrials.gov Identifier: NCT00695968

Recruitment Status : Terminated (low accrual)

First Posted : June 12, 2008

Last Update Posted : July 12, 2012

Sponsor:

Information provided by (Responsible Party):

Stanford University

Study Description

Brief Summary:

To determine the sensitivity, specificity, and accuracy of preoperative ultrasound, elastography, mammography and breast MRI in women with dense breast tissue diagnosed with breast cancer; to test whether elastography or MRI can improve upon routine mammogram and conventional ultrasound in women with dense breast tissue.

Condition or disease
Breast Cancer

Study Design


Study Type :	Observational
Actual Enrollment :	9 participants
Observational Model:	Cohort
Time Perspective:	Prospective
Official Title:	A Prospective Study Evaluating Breast Density and the Role of Preoperative Mammography, Ultrasound, Elastography, and Magnetic Resonance Imaging in the Detection of Breast Cancer
Study Start Date :	April 2008
Actual Primary Completion Date :	December 2011
Actual Study Completion Date :	December 2011

Resource links provided by the National Library of Medicine

Genetics Home Reference related topics: Breast cancer

MedlinePlus related topics: Breast Cancer Mammography

U.S. FDA Resources

Groups and Cohorts

Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years to 80 Years (Adult, Senior)
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Patients must have a suspicious breast lesion

Criteria

Inclusion Criteria:- Patients must have a suspicious breast lesion detected by a physical exam, mammography or U/S . that has not been surgically resected and is being considered to undergo biopsy if clinically indicated.

Patients must be >= 18 and < 80 years of age, and female.
Patients must have the ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:- Patients who have already had primary surgical excision of the suspicious finding

<18 or >80 years of age
Pregnant or Lactating Women

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00695968

Locations


United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305

Sponsors and Collaborators

Stanford University

Investigators


Principal Investigator:	Debra M Ikeda	Stanford University

More Information


Responsible Party:	Stanford University
ClinicalTrials.gov Identifier:	NCT00695968 History of Changes
Other Study ID Numbers:	BRSNSTU0024 98159 ( Other Identifier: SU )
First Posted:	June 12, 2008 Key Record Dates
Last Update Posted:	July 12, 2012
Last Verified:	July 2012

Additional relevant MeSH terms:


Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases

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