Biennial CEM Screening for Breast Cancer
Recruiting in Palo Alto (17 mi)
+4 other locations
Overseen byWendie Berg, MD, PhD
Age: 18+
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Wendie Berg
Must not be taking: Chemotherapy, Benadryl
Disqualifiers: Breast implants, Kidney failure, Pregnancy, others
No Placebo Group
Approved in 3 Jurisdictions
Trial Summary
What is the purpose of this trial?This trial is testing if adding a special type of mammogram with a contrast dye to the regular 3D mammogram can better detect breast cancer in women who have had it before. The dye helps highlight cancerous areas, and the 3D images provide detailed views from different angles.
Will I have to stop taking my current medications?
The trial protocol does not specify whether you need to stop taking your current medications. However, if you have a mild sensitivity to iodinated contrast and are allergic to Benadryl, you will be excluded from the trial.
What data supports the effectiveness of the treatment Contrast-enhanced mammography (CEM) for breast cancer?
Research shows that contrast-enhanced spectral mammography (CESM), a type of CEM, increases the accuracy of breast cancer diagnosis and is a reliable tool for evaluating women recalled from breast cancer screening programs. It has been validated in studies with multiple radiologists and is considered to have low risks with potential clinical benefits.
12345Is contrast-enhanced mammography safe for humans?
Contrast-enhanced mammography (CESM) is generally considered safe, with low risks reported in studies. It uses contrast agents to improve imaging, and while there are some drawbacks like potential artifacts affecting image quality, the technique is reliable and holds clinical benefits.
34678How does biennial CEM screening for breast cancer differ from other treatments?
Biennial CEM (Contrast-Enhanced Mammography) screening is unique because it uses contrast agents to enhance mammography images, providing clearer and more detailed views of breast tissue compared to standard mammograms. This method is particularly useful for women recalled from breast cancer screening programs, offering a reliable and potentially more accurate diagnostic tool with lower risks and costs compared to other imaging techniques like MRI.
13479Eligibility Criteria
This trial is for asymptomatic women aged 30-79 with a history of breast cancer, at least one year post any breast cancer surgery or treatment, and scheduled for an annual mammogram. Excluded are those with stage 4 metastasis to certain areas, bilateral mastectomy, recent chemotherapy or MRI exams, implants in the breasts to be screened, kidney issues including failure or low filtration rate, pregnancy or lactation, single kidney possession, and severe iodinated contrast reactions.Inclusion Criteria
I am a woman aged 30-79, had breast cancer, finished treatment over a year ago, and am due for a mammogram with DBT.
Exclusion Criteria
Pregnancy or lactation
I had a mild reaction to contrast dye but can take Benadryl.
I am a woman with kidney issues or my kidney filtering rate is below 45 mL/min.
+7 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Baseline CEM Exam
Participants receive a baseline contrast-enhanced mammography exam along with their routine 3D mammography exam
1 day
1 visit (in-person)
Biennial CEM Exams
Participants receive contrast-enhanced mammography exams at 24 months and 48 months after their baseline exam, while continuing annual 3D mammography exams
48 months
2 visits (in-person) for CEM, annual visits for DBT
Follow-up
Participants are monitored for cancer detection rates, false-positive recall rates, and positive-predictive values
62 months
Participant Groups
The study is testing if adding biennial contrast-enhanced mammography (CEM) to annual 3D mammography improves detection rates of breast cancer without significantly increasing false positives among women who have previously had breast cancer.
1Treatment groups
Experimental Treatment
Group I: contrast-enhanced mammographyExperimental Treatment1 Intervention
Enrolled participants will receive a baseline contrast-enhanced mammography exam for breast cancer screening, along with their scheduled 3D mammography exam, then they will receive another CEM exam for breast cancer screening at 24 months after their baseline CEM exam, and then again at 48 months. All the while, participants will still receive their annual 3D mammography exam as per their usual routine care.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
UPMC Magee-Womens Imaging - Bethel ParkBethel Park, PA
UPMC Magee at the Lemieux Sports ComplexCranberry Township, PA
Magee Womancare MonroevilleMonroeville, PA
Magee-Womens HospitalPittsburgh, PA
More Trial Locations
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Who Is Running the Clinical Trial?
Wendie BergLead Sponsor
Breast Cancer Research FoundationCollaborator
References
Contrast-enhanced spectral mammography in recalls from the Dutch breast cancer screening program: validation of results in a large multireader, multicase study. [2020]Contrast-enhanced spectral mammography (CESM) is a promising problem-solving tool in women referred from a breast cancer screening program. We aimed to study the validity of preliminary results of CESM using a larger panel of radiologists with different levels of CESM experience.
Contrast-enhanced spectral mammography in patients referred from the breast cancer screening programme. [2022]Feasibility studies have shown that contrast-enhanced spectral mammography (CESM) increases diagnostic accuracy of mammography. We studied diagnostic accuracy of CESM in patients referred from the breast cancer screening programme, who have a lower disease prevalence than previously published papers on CESM.
Contrast-enhanced spectral mammography as work-up tool in patients recalled from breast cancer screening has low risks and might hold clinical benefits. [2018]Contrast-enhanced spectral mammography (CESM) is a reliable problem solving tool in the work-up of women recalled from breast cancer screening. We evaluated additional findings caused by CESM alone and outweighed them against the disadvantages of this technique.
Diagnostic Value of Contrast-Enhanced Spectral Mammography for Screening Breast Cancer: Systematic Review and Meta-analysis. [2019]Contrast-enhanced spectral mammography (CESM) is a new image examination technology that has developed over the past few years. As CESM technology keeps improving, a current meta-analysis review is needed to systematically evaluate the potential diagnostic value of CESM.
Correlation between quantitative assessment of contrast enhancement in contrast-enhanced spectral mammography (CESM) and histopathology-preliminary results. [2020]Contrast-enhanced spectral mammography (CESM) is a novel method for breast cancer detection. The aim of this study is to check if there is a possibility of quantitative assessment of contrast enhancement in CESM and if there is any correlation between quantitative assessment of contrast enhancement in CESM and histopathology.
Contrast-enhanced Spectral Mammography: Technique, Indications, and Clinical Applications. [2022]Contrast-enhanced spectral mammography (CESM) combines the benefits of full field digital mammography with the concept of tumor angiogenesis. Technique and practical applications of CESM are discussed.
Dual-energy contrast-enhanced spectral mammography (CESM). [2018]Dual-energy contrast-enhanced mammography is one of the latest developments in breast care. Imaging with contrast agents in breast cancer was already known from previous magnetic resonance imaging and computed tomography studies. However, high costs, limited availability-or high radiation dose-led to the development of contrast-enhanced spectral mammography (CESM). We reviewed the current literature, present our experience, discuss the advantages and drawbacks of CESM and look at the future of this innovative technique.
Contrast-enhanced Spectral Mammography: Modality-Specific Artifacts and Other Factors Which May Interfere with Image Quality. [2018]Contrast-enhanced spectral mammography (CESM) uses full field digital mammography with the added benefit of intravenous contrast administration to significantly reduce false-positive and false-negative results and improve specificity while maintaining high sensitivity. For CESM to fulfill its purpose, one should be aware of possible artifacts and other factors which may interfere with image quality, and attention should be taken to minimize these factors.
Evaluation of low-energy contrast-enhanced spectral mammography images by comparing them to full-field digital mammography using EUREF image quality criteria. [2020]Contrast-enhanced spectral mammography (CESM) examination results in a low-energy (LE) and contrast-enhanced image. The LE appears similar to a full-field digital mammogram (FFDM). Our aim was to evaluate LE CESM image quality by comparing it to FFDM using criteria defined by the European Reference Organization for Quality Assured Breast Screening and Diagnostic Services (EUREF).