Molecular Breast Imaging for Dense Breasts
(MBI-GB-Pilot Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a screening method called Molecular Breast Imaging (MBI) to determine if it detects breast cancer more effectively than the usual 3D mammogram (DBT) in women with dense breasts. It also examines whether MBI results in more call-backs for biopsies and how well MBI-guided biopsies align with lab results. Women with dense breasts, characterized by more fibrous tissue than fatty tissue, may be suitable for this study. Participants will undergo both types of screenings and, if necessary, a biopsy guided by one of the methods. As an unphased trial, this study allows participants to contribute to important research that could enhance breast cancer detection methods.
Do I need to stop taking my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What prior data suggests that molecular breast imaging is safe for women with dense breasts?
Research shows that Molecular Breast Imaging (MBI) is safe for regular screening. Studies have found that patients tolerate MBI well, and it uses a very low amount of radiation, making it safe for routine use. Additionally, MBI-guided biopsy, which might be part of the trial, is safe and reliable for obtaining breast tissue samples. Although all medical tests carry some risks, evidence suggests that both MBI and MBI-guided biopsy are safe options for women with dense breast tissue.12345
Why are researchers excited about this trial?
Molecular Breast Imaging (MBI) is unique because it offers a new approach to screening for women with dense breast tissue, which can make detecting cancer more challenging with traditional mammography. Unlike standard methods like Digital Breast Tomosynthesis (DBT), MBI uses a special gamma camera to highlight areas of concern, potentially spotting cancers that other techniques might miss. Researchers are excited about MBI because it could improve early detection rates in dense breasts, leading to better outcomes and potentially reducing the need for invasive biopsies.
What evidence suggests that molecular breast imaging is effective for detecting cancer in dense breasts?
Research shows that Molecular Breast Imaging (MBI), studied in this trial, can more effectively detect breast cancer in women with dense breast tissue compared to traditional methods. Studies have found that MBI detects cancer in 12 out of every 1,000 women, while traditional 2D mammograms find about 3.2 out of 1,000. Additionally, when combined with regular mammograms, MBI can detect 7 to 8 more cancers per 1,000 women. This suggests that MBI might identify cancers that other methods miss, particularly in dense breasts. In this trial, MBI-guided biopsies are also under evaluation, with research suggesting they could enhance the accuracy of cancer detection.13467
Who Is on the Research Team?
James W Hugg, PhD
Principal Investigator
Smart Breast Corp.
Are You a Good Fit for This Trial?
This trial is for women with dense breast tissue, which can make it harder to spot cancer using standard mammograms. Participants will undergo advanced imaging techniques to improve detection.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Screening MBI and DBT
Participants receive both screening DBT and screening MBI to assess breast density and detect cancer
Biopsy
Participants receive either DBT-guided or MBI-guided biopsy if required by the screening images
Follow-up
Participants are monitored for safety and effectiveness after biopsy
What Are the Treatments Tested in This Trial?
Interventions
- MBI-guided biopsy
- Molecular Breast Imaging
Trial Overview
The study tests if Molecular Breast Imaging (MBI) is better than 3D mammography (DBT) at finding cancer in dense breasts. It also checks the accuracy of MBI-guided biopsies against pathology reports.
How Is the Trial Designed?
1
Treatment groups
Active Control
Screening DBT and screening MBI are compared in women with dense breasts. Then, DBT-guided biopsy and MBI-guided biopsy are compared.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Smart Breast Corp.
Lead Sponsor
University of Texas, Southwestern Medical Center at Dallas
Collaborator
National Cancer Institute (NCI)
Collaborator
Citations
Molecular Breast Imaging-guided Percutaneous Biopsy of ...
Molecular breast imaging as a supplemental imaging modality to mammography has shown an incremental cancer detection rate between 7.7 to 8.8 (33 ...
Molecular Breast Imaging May Benefit Women with Dense ...
New research highlights how molecular breast imaging may improve cancer detection in women with dense breasts, offering a valuable ...
Molecular Breast Imaging (MBI)-Guided Biopsy
The goal of this pilot clinical trial is to demonstrate supplemental screening MBI (molecular breast imaging) in women with dense breasts. The ...
Breast Density and Supplemental Screening
Haas et al found the greatest reduction in recall rate for women with extremely dense breasts with DBT (15.6% for 2D and 6.7% with DBT + 2D) (23). One single- ...
Comparison of supplemental breast cancer imaging ...
This study shows that supplemental imaging could lead to earlier detection of cancer in women with dense breasts but does not estimate the level ...
Molecular breast imaging
Risks. Molecular breast imaging is safe. Like every test, it carries certain risks and limitations. These might include:
Molecular Breast Imaging May Benefit Women with Dense ...
According to Dr. Hruska, MBI is considered safe for routine screening, is well-tolerated by patients and is relatively inexpensive. "MBI uses a ...
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