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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00695968
Recruitment Status : Terminated (low accrual)
First Posted : June 12, 2008
Last Update Posted : April 18, 2019
Sponsor:
Information provided by (Responsible Party):
Stanford University

Tracking Information
First Submitted Date June 10, 2008
First Posted Date June 12, 2008
Last Update Posted Date April 18, 2019
Study Start Date April 2008
Actual Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures
 (submitted: June 10, 2008)
To determine the sensitivity, specificity, and accuracy of EI in distinguishing breast cancer
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures
 (submitted: June 10, 2008)
  • To compare the specificity of EI given the influence of breast density masses or FFDM and (if available) MRI
  • To quantify breast density on FFDM and validate a new objective method to quantify Breast Density using novel R2 technology progress
  • To determine breast density on MRI using a novel computer based method
  • To correlate breast density on mammography, MRI and breast enhancement
  • To evaluate if breast density as defined on FFDM or MRI correlate with the performance on EI
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Breast Density and the Role of Preoperative Mammography, Ultrasound, Elastography and MRI
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
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients must have a suspicious breast lesion
Condition Breast Cancer
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Terminated
Actual Enrollment
 (submitted: July 10, 2012)
9
Original Enrollment
 (submitted: June 10, 2008)
250
Actual Study Completion Date December 2011
Actual Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00695968
Other Study ID Numbers BRSNSTU0024
98159 ( Other Identifier: SU )
BRSNSTU0024
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Stanford University
Study Sponsor Stanford University
Collaborators Not Provided
Investigators
Principal Investigator: Debra M Ikeda Stanford University
PRS Account Stanford University
Verification Date July 2012