Contrast Enhanced Spectral Mammography vs. MRI for Breast Cancer Screening

Breast Cancer Clinical Trial

Official title:

Contrast Enhanced Spectral Mammography vs. MRI for Breast Cancer Screening

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03482557
• Other study ID #: 17-689
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 17, 2018
• Est. completion date: August 30, 2023

Study information

• Verified date: June 2023
• Source: Beth Israel Deaconess Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 82
• Est. completion date: August 30, 2023
• Est. primary completion date: August 30, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 30 Years to 110 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

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
• MRI
MRI uses magnets to create a detailed image of the tissues and bones inside of the body

Locations

Country	Name	City	State
United States	Beth Israel Deaconess	Boston	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Beth Israel Deaconess Medical Center	Dana-Farber Cancer Institute, GE Healthcare

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic accuracy of CESM compared with breast MRI for breast cancer screening	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.	2 years
Secondary	Diagnostic accuracy of CESM compared with abbreviated MRI for breast cancer detection	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 years
Secondary	Diagnostic accuracy of CESM compared with conventional mammography for breast cancer screening	We will determine whether CESM is superior to conventional 2D mammographic screening using a multi-case multi-reader study model.	2 years
Secondary	Patient preference for breast MRI versus CESM for breast cancer screening	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	2 years