High Resolution 3D Diffusion-weighted Breast MRI

This study is currently recruiting participants.
Verified November 2013 by Stanford University
Sponsor:
Information provided by (Responsible Party):
Stanford University
ClinicalTrials.gov Identifier:
NCT01315106
First received: March 11, 2011
Last updated: November 6, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention
Breast Cancer
Metastatic Breast Cancer
Device: Magnetic Resonance Image Scanner

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: High Resolution 3D Diffusion-weighted Breast MRI

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Sensitivity of the new MRI method [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Lesion detection rate of the new MRI method [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 500
Study Start Date: March 2011
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Magnetic Resonance Image Scanner
    Magnetic Resonance Imaging; 1.5 Tesla or 3 Tesla MRI scanner
    Other Name: MRI
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Stanford Radiology Department MRI facilities

Criteria

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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01315106

Contacts
Contact: Alice Gardner (650) 725-1812 agardner@stanford.edu

Locations
United States, California
Stanford University School of Medicine Recruiting
Stanford, California, United States, 94305
Contact: Alice Gardner    650-725-1812    agardner@stanford.edu   
Contact: Cancer Clinical Trials Office    (650) 498-7061      
Principal Investigator: Bruce Lewis Daniel         
Sub-Investigator: Brian Andrew Hargreaves         
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Bruce Lewis Daniel Stanford University
  More Information

No publications provided

Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT01315106     History of Changes
Other Study ID Numbers: BRS0013, SU-11152010-7211, 19595
Study First Received: March 11, 2011
Last Updated: November 6, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on April 16, 2014