Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials
Text Size

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

This study has been terminated.
(low accrual)
Sponsor:
Information provided by (Responsible Party):
Stanford University
ClinicalTrials.gov Identifier:
NCT00695968
First received: June 10, 2008
Last updated: July 10, 2012
Last verified: July 2012
History of Changes
  Purpose

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
Breast Cancer

Study Type: Observational
Study Design: 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

Resource links provided by NLM:

MedlinePlus related topics: Mammography
U.S. FDA Resources

Further study details as provided by Stanford University:
Enrollment: 9
Study Start Date: April 2008
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
  Eligibility
Ages Eligible for Study:   18 Years to 80 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT00695968     History of Changes
Other Study ID Numbers: BRSNSTU0024, 98159, BRSNSTU0024
Study First Received: June 10, 2008
Last Updated: July 10, 2012
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on March 03, 2015