Comparing Restriction Spectrum Imaging (RSI) to Conventional and Abbreviated Breast MRI for Breast Cancer Screening
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|ClinicalTrials.gov Identifier: NCT03495115|
Recruitment Status : Recruiting
First Posted : April 11, 2018
Last Update Posted : July 30, 2018
This study is looking at a breast cancer screening technique, restriction spectrum imaging (RSI), as a possible alternative to the breast Magnetic Resonance Imaging (MRI) used by most healthcare professionals.
The technique involved in this study is:
-Restriction Spectrum Imaging (RSI)
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Device: MRI Device: RSI||Not Applicable|
The primary purpose of this research study is to measure RSI's ability to diagnose breast cancer in comparison to standard breast MRIs.
RSI is a technique that has been shown to address the limitations of certain types of MRI exams used to make images of the prostate and brain. RSI is not a FDA-approved technique for screening, but is a type of advanced diffusion technique and diffusion weighted imaging is used as a part of the standard breast MRI. RSI has been shown to improve tumor detection in prostate and brain. For example, a recent pilot study in prostate showed that adding RSI improved the ability to find a certain stage of prostate cancer in comparison to an MRI without the use of the RSI technique. By comparing RSI's ability to diagnose breast cancer, future clinical testing can determine whether RSI is a more efficient way to screen for breast cancer.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||910 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Comparing Restriction Spectrum Imaging (RSI) to Conventional and Abbreviated Breast MRI for Breast Cancer Screening|
|Actual Study Start Date :||April 18, 2018|
|Estimated Primary Completion Date :||April 15, 2021|
|Estimated Study Completion Date :||April 15, 2021|
Active Comparator: SCREENING MRI
Standard MRI procedure will be used.
A MRI uses a strong magnet to produce detailed pictures of the inside of your body.
Experimental: SCREENING MG BI-RADS 4/5
RSI is a technique that aims to improve the pictures produced during a MRI exam.
- Diagnostic accuracy of breast restriction spectrum imaging (RSI) in comparison to conventional breast MRI [ Time Frame: 2 years ]We will test the non-inferiority of RSI compared to DCE-MRI using ROC curves created for the BI-RADS score, based on the reader study.
- Diagnostic accuracy of RSI compared to that of abbreviated MRI (Ab-MRI) in breast cancer screening [ Time Frame: 2 years ]We will test the non-inferiority of RSI compared to Ab-MRI using ROC curves created for the BI-RADS score, based on the reader study.
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): NCT03495115
|Contact: Vandana Dialani, MDfirstname.lastname@example.org|
|United States, Massachusetts|
|Beth Israel Deaconess Medical Center||Recruiting|
|Boston, Massachusetts, United States, 02215|
|Contact: Vandana Dialani, MD 617-667-3118 email@example.com|
|Principal Investigator: Vandana Dialani, MD|
|Principal Investigator:||Vandana Dialani, MD||Beth Israel Deaconess Medical Center|