Contrast Enhanced Spectral Mammography vs. MRI for Breast Cancer Screening

• ClinicalTrials.gov Identifier: NCT03482557
• Recruitment Status: Active, not recruiting
• First Posted: March 29, 2018
• Last Update Posted: February 9, 2023
• Sponsor: Dana-Farber Cancer Institute
• Collaborator: GE Healthcare
• Information provided by (Responsible Party): Vandana Dialani, MD, Dana-Farber Cancer Institute

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Breast Cancer	Device: CESM; Device: MRI	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 82 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Screening
• Official Title: Contrast Enhanced Spectral Mammography vs. MRI for Breast Cancer Screening
• Actual Study Start Date: May 17, 2018
• Estimated Primary Completion Date: August 30, 2023
• Estimated Study Completion Date: August 30, 2023

Arms and Interventions

Arm

Intervention/treatment

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.

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; Other Name: Contrast Enhanced Spectral Mammography; Device: MRI; MRI uses magnets to create a detailed image of the tissues and bones inside of the body; Other Name: Magnetic Resonance Imaging

Outcome Measures

Primary Outcome Measures :

1. 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 Outcome Measures :

1. 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.
2. 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.
3. 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

Eligibility Criteria

• Ages Eligible for Study: 30 Years to 110 Years (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

United States, Massachusetts

Beth Israel Deaconess

Boston, Massachusetts, United States, 02215

Sponsors and Collaborators

Dana-Farber Cancer Institute

GE Healthcare

Investigators

• Principal Investigator: Vandana Dialani, MD; Beth Israel Deaconess Medical Center

More Information

• Responsible Party: Vandana Dialani, MD, Principal Investigator, Dana-Farber Cancer Institute
• ClinicalTrials.gov Identifier: NCT03482557
• Other Study ID Numbers: 17-689
• First Posted: March 29, 2018
• Last Update Posted: February 9, 2023
• Last Verified: February 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No

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

Breast Cancer; screening; breast MRI; contrast enhanced spectral mammography

Additional relevant MeSH terms:

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases