Restriction Spectrum Imaging or Conventional and Abbreviated MRI in Screening Participants Who May Have Breast Cancer

Status: Active

Description

This trial compares restriction spectrum imaging (RSI) with conventional and abbreviated magnetic resonance imaging (MRI) in screening participants who may have breast cancer. MRI uses a strong magnet to produce detailed pictures of the inside of the body and RSI is a technique that aims to improve the pictures produced during a MRI exam. RSI may be a better way to screen for breast cancer.

Eligibility Criteria

Inclusion Criteria

  • INCLUSION - PATIENT: Women presenting for breast cancer screening with either MRI or mammography: Group 1 will consist of women who present for screening breast MRI: * Asymptomatic for breast disease * Presenting for routine breast cancer screening with MRI
  • INCLUSION - PATIENT: Group 2 will consist of women who presented for a screening mammogram (2 dimensional [D] or 3D tomosynthesis) AND who have had a biopsy recommended after diagnostic workup: * Initial presentation for routine breast cancer screening with mammogram (2D or 3D tomosynthesis) and/or ultrasound and * Biopsy recommended after subsequent diagnostic workup (breast imaging reporting and data system [BI-RADS] 4 or 5)
  • INCLUSION - RADIOLOGIST READER: Must have clinical experience in interpreting breast MRI
  • INCLUSION - RADIOLOGIST READER: Must have interpreted at least 10 breast MRI exams with RSI interpretation

Exclusion Criteria

  • EXCLUSION - PATIENT: 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: * Known history of end stage renal disease with estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m^2 * 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) answered yes to any of the Choyke question AND no creatinine result is available in the optical mark recognition (OMR) software within 30 days of the MRI exam, regardless of patient age, or (b) the patient is > 60 years old, or (c) the patient is on hydroxyurea
  • EXCLUSION - PATIENT: 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
  • EXCLUSION - PATIENT: 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
  • EXCLUSION - PATIENT: Unable to tolerate exam (i.e., secondary to untreatable claustrophobia, positioning constraints/unable to lie prone)
  • EXCLUSION - PATIENT: Body weight exceeds that allowable by the MRI table
  • EXCLUSION - PATIENT: Breast biopsy or surgical intervention planned before the test RSI-MRI in this study
  • EXCLUSION - PATIENT: Breast implants (silicone or saline)
  • EXCLUSION - PATIENT: Nursing or thinks she may be or is pregnant; 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)

Locations & Contacts

Massachusetts

Boston
Beth Israel Deaconess Medical Center
Status: Active
Contact: Vandana Dialani
Phone: 617-667-5681
Email: vdialani@bidmc.harvard.edu

Trial Objectives and Outline

PRIMARY OBJECTIVE:

I. To measure the diagnostic accuracy of breast restriction spectrum imaging (RSI) in comparison to conventional breast MRI (dynamic contrast-enhanced MRI with diffusion weighted imaging; DCE-MRI+DWI) for breast cancer screening.

SECONDARY OBJECTIVE:

I. To measure the diagnostic accuracy of RSI compared to that of abbreviated MRI (Ab-MRI) in breast cancer screening.

OUTLINE: Participants are assigned to 1 of 2 groups.

GROUP 1: Participants receive gadolinium intravenously (IV) and undergo standard MRI (DCE-MRI+DWI) and Ab-MRI over 30 minutes.

GROUP 2: Participants undergo standard MRI and Ab-MRI as in Group 1 and RSI over 5 minutes.

Trial Phase & Type

Trial Phase

No phase specified

Trial Type

Screening

Lead Organization

Lead Organization
Dana-Farber Harvard Cancer Center

Principal Investigator
Vandana Dialani

Trial IDs

Primary ID 17-552
Secondary IDs NCI-2018-00799
Clinicaltrials.gov ID NCT03495115