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High Resolution 3D Diffusion-weighted Breast 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: NCT01315106
Recruitment Status : Active, not recruiting
First Posted : March 15, 2011
Last Update Posted : June 23, 2022
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Stanford University

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment
Breast Cancer Metastatic Breast Cancer 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 Design
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Study Type : Observational
Actual Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: High Resolution 3D Diffusion-weighted Breast MRI
Study Start Date : March 2011
Estimated Primary Completion Date : December 2024
Estimated Study Completion Date : February 2025

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Intervention Details:
  • Device: Magnetic Resonance Image Scanner
    Magnetic Resonance Imaging; 1.5 Tesla or 3 Tesla MRI scanner
    Other Name: MRI

Outcome Measures
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Primary Outcome Measures :
  1. Sensitivity of the new MRI method [ Time Frame: 8 weeks ]
  2. Lesion detection rate of the new MRI method [ Time Frame: 4 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes 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
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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): NCT01315106


Locations
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United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
National Institutes of Health (NIH)
Investigators
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Principal Investigator: Bruce L. Daniel Stanford University
More Information
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Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT01315106    
Other Study ID Numbers: IRB-19595
SU-11152010-7211 ( Other Identifier: Stanford University )
BRS0013 ( Other Identifier: OnCore )
First Posted: March 15, 2011    Key Record Dates
Last Update Posted: June 23, 2022
Last Verified: June 2022
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases