Breast Cancer
Conditions
Keywords
Breast Cancer
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)
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.
Interventions
DEVICEMRI
A MRI uses a strong magnet to produce detailed pictures of the inside of your body.
DEVICERSI
RSI is a technique that aims to improve the pictures produced during a MRI exam.
Sponsors
Beth Israel Deaconess Medical Center
Radiological Society of North America
Dana-Farber Cancer Institute
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic Accuracy of Restriction Spectrum Imaging (RSI) in Comparison to Conventional Breast MRI for Detection of Breast Cancer in the Screening Population. | 2 years | Comparison of participants with cancer in the DCE- MRI group compared to RSI group. Review of the examinations was performed by 3 expert breast imagers and number of cancers detected in each group were compared. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORVandana Dialani, MD
Beth Israel Deaconess Medical Center
Participant flow
Recruitment details
Group1- Conventional Breast MRI Group 2 - Restriction spectrum imaging
Pre-assignment details
Total 460 patients in each arm - 420 subjects were in screening population for high risk screening forming group 1 and 40 patients with BIRADS 4/5 getting a breast MRI prior to biopsy forming group 2. Both groups together were used for each arm which had the same population of 460 patients.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 60 Participants |
| Age, Categorical Between 18 and 65 years | 400 Participants |
| Region of Enrollment United States | 460 Participants |
| Sex/Gender, Customized SEX FEMALE | 460 Participants |
| Sex/Gender, Customized SEX MALE | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 460 | 0 / 460 |
| other Total, other adverse events | 0 / 460 | 0 / 460 |
| serious Total, serious adverse events | 0 / 460 | 0 / 460 |
Outcome results
None listed