Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Comparing Restriction Spectrum Imaging (RSI) to Conventional and Abbreviated Breast MRI for Breast Cancer Screening

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03495115
Recruitment Status : Recruiting
First Posted : April 11, 2018
Last Update Posted : July 30, 2018
Sponsor:
Collaborator:
Radiological Society of North America
Information provided by (Responsible Party):
Vandana Dialani, Dana-Farber Cancer Institute

Brief Summary:

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

Detailed Description:

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 910 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: SCREENING MRI
Standard MRI procedure will be used.
Device: MRI
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 DWI sequence with a built in distortion-correction technique that can be applied to any diffusion technique using echo planar imaging acquisition.
  • RSI will be performed using pulsed-field gradient, spin-echo, echo planar imaging with "multi-shell" diffusion data .
  • The b0 images will be collected in both the forward and reverse phase encoding directions to allow for post-processing correction of spatial distortion from magnetic field.
Device: RSI
RSI is a technique that aims to improve the pictures produced during a MRI exam.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Group 1 will consist of women who present for screening breast MRI:

    • Age >= 18
    • Female
    • Asymptomatic for breast disease
    • Presenting for routine breast cancer screening with MRI
  • Group 2 will consist of women who presented for a screening mammogram (2D or 3D tomosynthesis) AND who have had a biopsy recommended after diagnostic workup:

    • Age >= 18
    • Female
    • Asymptomatic for breast disease
    • Presenting for routine breast cancer screening with mammogram (2D or 3D tomosynthesis) and/or ultrasound
    • Biopsy recommended after subsequent diagnostic workup (BI-RADS 4 or 5)

Radiologist Reader Participant

Inclusion Criteria

  • Must have clinical experience in interpreting breast MRI.
  • Must have interpreted at least 10 breast MRI exams with RSI interpretation.

Exclusion Criteria:

-Known or suspected renal insufficiency, rendering the participant unable to safely receive intravenous contrast based on institutional clinical protocol.

Renal insufficiency for the purposes of exclusion includes any of the following:

  • Failed Chokye questionnaire
  • Known history of end stage renal disease with EGFR<30 mL/min/1.73m2
  • Point of care (POC) measure of creatinine clearance (eGFR) prior to obtaining the MRI <35. We will perform this POC test as needed per institutional policy for routine MRI if: (a) no creatinine result is available in the OMR within 30 days of the MRI exam, (b) the patient is > 60 years old, or (c) the patient is on hydroxyurea.

    • History of adverse or allergic-like reaction to gadolinium MRI intravenous contrast, rendering the participant unable to safely receive intravenous contrast based on institutional clinical protocol.
    • Presence of MRI unsafe devices or objects which would make having an MRI unsafe, as per institutional clinical protocol. MRI unsafe devices or objects for the purposes of exclusion include but are not limited to certain intracranial aneurysm clips, cardiac pacemaker, and implantable defibrillator devices, metallic heart valve, or coronary artery stents, breast tissue expanders, bio or neurostimulators, pellets and bullets, ocular implants and devices, otologic and cochlear implants. Other devices or metallic objects may be deemed unsafe for MRI at the radiologist's discretion.
    • Unable to tolerate exam (i.e., secondary to untreatable claustrophobia, positioning constraints/unable to lie prone).
    • Body weight exceeds that allowable by the MRI table.
    • Breast biopsy or surgical intervention planned before the test RSI-MRI in this study.
    • Breast implants (silicone or saline).

      8. Nursing or thinks she may be or is pregnant, as gadolinium contrast-enhanced MRI is unsafe. We will perform a pregnancy test as needed per institutional policy for routine breast MRI. Per institutional clinical protocol, all females of childbearing potential who are uncertain if they are pregnant or think they are pregnant must have a blood test or urine study within 2 weeks prior to the MRI exam to rule out pregnancy. A female of childbearing potential is any woman, regardless of sexual orientation or prior tubal ligation, who:

    • Has not had a hysterectomy or bilateral oophorectomy OR
    • Has not been naturally post-menopausal for at least 2 years (i.e., has had menses at any time in the preceding 2 years

Radiologist Reader Participant

-None.


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): NCT03495115


Contacts
Layout table for location contacts
Contact: Vandana Dialani, MD 617-667-3118 vdialani@bidmc.harvard.edu

Locations
Layout table for location information
United States, Massachusetts
Beth Israel Deaconess Medical Center Recruiting
Boston, Massachusetts, United States, 02215
Contact: Vandana Dialani, MD    617-667-3118    vdialani@bidmc.harvard.edu   
Principal Investigator: Vandana Dialani, MD         
Sponsors and Collaborators
Dana-Farber Cancer Institute
Radiological Society of North America
Investigators
Layout table for investigator information
Principal Investigator: Vandana Dialani, MD Beth Israel Deaconess Medical Center

Layout table for additonal information
Responsible Party: Vandana Dialani, Principal Investigator, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT03495115     History of Changes
Other Study ID Numbers: 17-552
First Posted: April 11, 2018    Key Record Dates
Last Update Posted: July 30, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No

Keywords provided by Vandana Dialani, Dana-Farber Cancer Institute:
Breast Cancer

Additional relevant MeSH terms:
Layout table for MeSH terms
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases