Contrast Enhanced Spectral Mammography vs. MRI for Breast Cancer Screening

Overview

This research study is evaluating whether contrast enhanced mammography can be used as an alternative to breast Magnetic Resonance Imaging (MRI) for cancer screening

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Screening
    • Masking: None (Open Label)
  • Study Primary Completion Date: April 30, 2021

Detailed Description

Mammography is the main way to help find breast cancers early so they can be treated. Unfortunately, mammography does not work as well in women who have dense breast tissue or who are at high-risk for breast cancer. In these women, breast MRI is also used to help find breast cancers.

Contrast enhanced mammography is a new type of mammogram. It uses contrast material combined with the mammogram to highlight areas that might be breast cancer and that could be missed on the mammogram alone. This is similar to breast MRI.

For this study, participants who are already getting a breast biopsy will have a contrast enhanced mammogram and a breast MRI before the biopsy. The participant's contrast enhanced mammogram and breast MRI images will then be included within a large collection of images. Radiologists will compare the images to see if the contrast enhanced mammograms and the breast MRI find the same number of breast cancers. If the investigators find they perform similarly, then contrast mammography may be used to aid in breast cancer screening in the future.

Interventions

  • Device: CESM
    • Contrast enhanced mammography is a new type of mammogram. It uses contrast material combined with the mammogram to highlight areas that might be breast cancer and that could be missed on the mammogram alone
  • Device: MRI
    • MRI uses magnets to create a detailed image of the tissues and bones inside of the body

Arms, Groups and Cohorts

  • Experimental: CESM VS MRI
    • Each enrolled participant will receive both a CESM and MRI exam prior to the breast biopsy, if they had not been performed already as part of clinical care. MRI: Breast MRI will be performed, if not already performed as part of clinical care. CESM: After the MRI is complete, patients will be brought to the mammography department for the contrast enhanced mammogram. The CESM will only occur if not already performed as part of the patient’s clinical care. Biopsy: Patients will then have their biopsy. Any additional findings seen on the CESM or MRI will be worked up also. Reader Study: The CESM and the MRI images will be included in a case set that is ready by 10 study radiologists at a later date, after the biopsy is performed. These radiologists will look at the images to see if CESM and MRI find the same number of breast cancers.

Clinical Trial Outcome Measures

Primary Measures

  • Diagnostic accuracy of CESM compared with breast MRI for breast cancer screening
    • Time Frame: 2 years
    • We will determine whether CESM is non-inferior to breast MRI for breast cancer detection by comparing cancer detection rates on both studies using a multi-case multi-reader study model.

Secondary Measures

  • Diagnostic accuracy of CESM compared with abbreviated MRI for breast cancer detection
    • Time Frame: 2 years
    • We will determine whether CESM is non-inferior to abbreviated breast MRI for breast cancer detection by comparing cancer detection rates on both studies using a multi-case multi-reader study model.
  • Diagnostic accuracy of CESM compared with conventional mammography for breast cancer screening
    • Time Frame: 2 years
    • We will determine whether CESM is superior to conventional 2D mammographic screening using a multi-case multi-reader study model.
  • Patient preference for breast MRI versus CESM for breast cancer screening
    • Time Frame: 2 years
    • We will provide each patient with a survey following completing of the CESM and MRI exams to understand which exam the patients prefer for breast cancer screening

Participating in This Clinical Trial

Inclusion Criteria

Prospective Patient Recruitment

  • Women
  • Age > or equal to 30 years
  • Recommendation for breast biopsy has been made
  • Recommendation for biopsy will result from an imaging work-up originating with a screening exam (mammogram, tomosynthesis, ultrasound, or MRI) that was within 3 months of biopsy.

Reader Study Inclusion Criteria:

  • CESM and MRI exam performed within 3 months of one another.
  • CESM and breast MRI exams must be performed as part of imaging work-up based on a screening exam of any type (mammography, tomosynthesis, ultrasound, and MRI)
  • CESM studies will include at least four low energy and four recombined images (LCC, LMLO, RCC, RMLO).
  • MRI exams will include at least fluid sensitive sequence, multi-phase T1-weighted

Exclusion Criteria

Prospective Patient Recruitment

  • Men
  • Women with implants
  • Participants who have a known allergy to contrast media.
  • Participants who have a known severe allergic response to one or more allergens, defined as anaphylaxis
  • Participants with poor asthma control using the National Heart, Lung, and Blood Institute guidelines as defined by:

Symptoms > 2 days per week Short-term beta agonist use > 2 days per week Nighttime awakenings > 2 times per month

  • Participants with Renal insufficiency or failure, as determined by GFR < 60 mL/min/1.73 m2 , performed for all patients within 24 hours of the imaging exams
  • Participants who are pregnant. Pregnant women are excluded from this study due to the radiation dose from the CT scan and its potential teratogenic effects on the fetus.
  • Participants who are breastfeeding are excluded because there is an unknown but potential risk for adverse events in nursing infants secondary to contrast administration in the mother.
  • Participants with the following underlying medical conditions: multiple myeloma, myasthenia gravis, dysproteinemias, severe cardiac disease, aortic stenosis, primary pulmonary hypertension, cardiac arrythmia, or severe cardiomyopathy. These underlying medical conditions may make the participant more likely to develop a contrast reaction. This is based on the ACR contrast manual version 10.3 and hospital policy.
  • Participants with a concurrent active illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, thyroid storm.
  • Participants with thyroid carcinoma or thyroid disease for whom systemic radioactive iodine therapy is part of planned diagnostic work-up or treatment within 2 months following the contrast mammogram study.
  • Participants with non-MR compatible objects or implants that would make MRI a contraindication.
  • Participants who have a pacemaker, pacer wires, implantable defibrillator, or implanted monitoring device.
  • Participants with intracranial clips, metal implants or external clips within 10 mm of the head.
  • Participants who have had a metal injury to the eye.

Reader Study Exclusion Criteria:

  • Imaging sets with implants.
  • Imaging sets in which a biopsy or surgical intervention was performed since the most recent screening exam, prior to acquisition of the study MRI or CESM.
  • Imaging sets in which a biopsy was recommended, but biopsy was not performed and 2 year imaging follow-up is not available

Gender Eligibility: Female

Minimum Age: 30 Years

Maximum Age: 110 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Dana-Farber Cancer Institute
  • Collaborator
    • GE Healthcare
  • Provider of Information About this Clinical Study
    • Principal Investigator: Jordana Phillips, MD, Principal Investigator – Dana-Farber Cancer Institute
  • Overall Official(s)
    • Jordana Phillips, MD, Principal Investigator, Beth Israel Deaconess Medical Center
  • Overall Contact(s)
    • Jennifer Thompson, 617-667-3118, jthomps1@bidmc.harvard.edu

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.