High Resolution 3D Diffusion-weighted Breast MRI

The purpose of this study is to determine how well a new MRI technique called "High resolution 3D diffusion-weighted breast MRI" detects breast cancer.

Study Overview

• Status: Terminated
• Conditions: Breast Cancer; Metastatic Breast Cancer
• Intervention / Treatment: Device: Magnetic Resonance Image Scanner

Detailed Description

The objective of this study is to assess the diagnostic accuracy of a new non-contrast MRI method for breast cancer detection. The study design is a single arm observational study. The new technique will be added on to the standard sequences that a women undergoes during a breast MRI. The resulting images will be compared with her standard breast MRI images, and with results of subsequent pathology.

• Study Type: Observational
• Enrollment (Actual): 50

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Stanford Radiology Department MRI facilities

Description

Inclusion Criteria:1. Patient scheduled for contrast-enhanced breast MRI to image possible breast cancer.

2. Female

3. Age >18 Exclusion Criteria:1. Lactation

2. Pregnancy

3. Patient undergoing chemotherapy. These patients are excluded because chemotherapy changes the biology of breast cancers. Since the ultimate objective of the research is to develop a new imaging method for breast MRI screening (detection of previously unknown tumors), results in treated tumors would not be relevant. Including treated tumors could yield a misleading assessment of the performance of the new method since treated tumors have different imaging characteristics than de novo tumors.

4. Patient scheduled for pre-operative chemotherapy. These patients are excluded if they are going to be treated only on the basis of fine needle aspiration. The project seeks to correlate all tumors detected with standard histopathology of their untreated neoplasm. This exclusion criteria will be very unusual because most patients planning neoadjuvant chemotherapy do so on the basis of a pre-chemo core needle biopsy, which provide adequate histopathologic proof necessary for enrollment.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Sensitivity of the new MRI method	8 weeks
Lesion detection rate of the new MRI method	4 weeks

Collaborators and Investigators

• Sponsor: Stanford University
• Collaborators: National Institutes of Health (NIH); National Institute for Biomedical Imaging and Bioengineering (NIBIB)
• Investigators: Principal Investigator: Bruce L. Daniel, Stanford University

Study record dates

Study Major Dates

• Study Start: March 1, 2011
• Primary Completion (Actual): January 7, 2014
• Study Completion (Actual): January 7, 2014

Study Registration Dates

• First Submitted: March 11, 2011
• First Submitted That Met QC Criteria: March 11, 2011
• First Posted (Estimated): March 15, 2011

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 13, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: IRB-19595; SU-11152010-7211 (Other Identifier: Stanford University); BRS0013 (Other Identifier: OnCore); 5R21EB012591-02 (U.S. NIH Grant/Contract)