Supplemental Imaging for Breast Cancer
(PSID Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine if adding MRI, a detailed imaging technique, to regular mammogram screenings can better detect breast cancer in women with extremely dense breasts. Researchers are using a new tool, Prognosia Breast, to identify women at higher risk of breast cancer. Participants will receive either a mammogram alone or both an MRI and a mammogram to compare outcomes. Women with dense breasts and a normal mammogram within the last 90 days might be suitable for this study. As an unphased trial, this study offers participants the chance to contribute to important research that could enhance breast cancer detection methods.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are receiving any chemoprevention (medication to prevent cancer).
What prior data suggests that this imaging technique is safe for breast cancer screening?
Research shows that MRI scans, which use magnets and radio waves to capture images inside the body, are safe for women with dense breast tissue. Studies have found that combining MRI scans with regular mammograms helps detect breast cancer earlier, improving survival chances.
The MRI technology, called Prognosia Breast, estimates the risk of developing breast cancer more accurately than some traditional methods. While specific side effects are not detailed, similar studies have shown that MRI use is generally well-tolerated, with no major safety concerns reported.
In summary, MRIs are generally safe and effective for detecting breast cancer in high-risk women, with a good safety record in previous studies.12345Why are researchers excited about this trial?
Researchers are excited about this trial because it explores the potential benefits of using MRIs as part of breast cancer screening. Unlike the standard approach, which typically involves annual mammograms, this trial looks at how adding MRIs might improve detection rates or provide more detailed imaging. By comparing MRIs with regular mammograms, researchers hope to determine if MRIs can offer better early detection, potentially leading to earlier and more effective treatment of breast cancer.
What evidence suggests that this trial's treatments could be effective for breast cancer?
Research has shown that using MRI scans for breast cancer screening in women with dense breasts can detect cancers that regular mammograms might miss. Studies have found that combining MRI with mammograms detects more cancers, especially in women at high risk. For instance, one study discovered that MRI found 32 breast cancers, with 22 of these not seen on mammograms. This indicates that MRI can identify cancers that regular mammograms might overlook. In this trial, participants in Arm A will undergo an MRI and subsequent annual screening mammogram with MRI, while those in the Feasibility arm will be recommended to undergo MRI. Arm B participants will receive regular care with annual screening mammograms. Using MRI along with mammograms helps detect cancer early and improves the chances of successful treatment. This method is particularly beneficial for women at higher risk of breast cancer.26789
Who Is on the Research Team?
Tabassum Ahmad, M.D.
Principal Investigator
Washington University School of Medicine
Are You a Good Fit for This Trial?
This trial is for women with extremely dense breasts who have had normal mammogram results. It's designed to see if additional imaging like MRI can help reduce the risk of breast cancer that might be missed between regular screenings.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Feasibility
Participants are recommended to undergo MRI and followed to determine completion
Regular Care
Participants undergo annual screening mammogram per standard of care
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Prognosia Breast
Trial Overview
The study is testing a new model called Prognosia Breast, which calculates a woman's 5-year risk of breast cancer using mammogram images and compares it to standard screening methods like mammograms alone or with supplemental MRI.
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Active Control
Consenting and eligible participants will be recommended to undergo MRI and will be followed to determine whether they complete the MRI.
Consenting and eligible participants will undergo an MRI and subsequent annual screening mammogram with MRI.
Consenting and eligible participants will undergo annual screening mammogram per standard of care.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Washington University School of Medicine
Lead Sponsor
Citations
Survival Outcomes of Screening with Breast MRI in Women ...
Combined screening with MRI and mammography in women at elevated risk of breast cancer improves cancer detection and overall survival.
Outcomes of High-Risk Breast MRI Screening in Women ...
High-risk screening breast MRI was effective at detecting early breast cancer and associated with favorable outcomes.
MRI Surveillance and Breast Cancer Mortality in Women ...
Results of this study suggest that among women with a BRCA1 sequence variation, MRI surveillance is associated with reduced breast cancer mortality risk.
4.
breastsurgeons.org
breastsurgeons.org/docs/statements/Consensus-Guideline-on-Diagnostic-and-Screening-Magnetic-Resonance-Imaging-of-the-Breast.pdfDiagnostic and Screening Magnetic Resonance Imaging of ...
In studies comparing the effectiveness of breast MRI to mammography for screening of high- risk women for breast cancer - including patients with BRCA mutations ...
Efficacy of MRI and Mammography for Breast-Cancer ...
Overall, 32 breast cancers were found by MRI (22 of these were not visible on mammography), whereas 13 were missed by MRI (8 of the 13 were visible on ...
AI-Based Self-Supervised Learning Model Using Non ...
The expected outcome of this study is to provide robust evidence supporting the clinical feasibility of AI-guided non-contrast MRI as a safe, ...
7.
medicine.washu.edu
medicine.washu.edu/news/ai-based-breast-cancer-risk-technology-receives-fda-breakthrough-device-designation/AI-based breast cancer risk technology receives FDA ...
According to the developers, Prognosia Breast estimates a person's five-year risk of developing breast cancer 2.2 times more accurately than the ...
Using AI to Select Women with Intermediate Breast Cancer ...
AI showed the potential to detect 84% of breast cancers, including 68% of mammographically occult cancers, at a supplemental breast MRI rate of ...
Early Detection of Breast Cancer in MRI Using AI
Within a high-risk population, we observed an ROC–AUC of 0.72 in predicting cancer at a 1-year follow-up (0–15 months) using MRI. It's worth noting that recent ...
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.