Biennial CEM Screening for Breast Cancer

Recruiting at 5 trial locations

Overseen By McKenna Rigling, MS

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Wendie Berg

Must not be taking: Chemotherapy, Benadryl

Disqualifiers: Breast implants, Kidney failure, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

1500 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether adding contrast-enhanced mammography (CEM) every two years to regular yearly 3D mammograms can better detect breast cancer in women with a history of the disease. The goal is to catch any new cancer early while reducing false alarms. Women who have had breast cancer, are at least a year past their treatment, and are due for their yearly mammogram might be suitable candidates. As an unphased trial, this study offers a unique opportunity to contribute to research that could enhance early cancer detection methods.

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 prior data suggests that contrast-enhanced mammography is safe for breast cancer screening?

Research shows that contrast-enhanced mammography (CEM) is a promising method for detecting breast cancer. It effectively identifies cancer. Safety concerns typically involve radiation exposure and reactions to the contrast dye used in the test.

Studies have examined these safety issues and found that the radiation levels in CEM remain within the safe limits used for other breast scans. Reactions to the contrast dye are generally rare and mild, similar to those in other imaging tests that use contrast.

Overall, CEM appears well-tolerated, with a safety profile similar to other standard imaging tests. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about contrast-enhanced mammography (CEM) because it offers a more detailed view of breast tissue compared to standard 3D mammography. Unlike traditional methods, CEM uses a special dye that highlights blood vessels in the breast, making it easier to spot abnormalities or cancerous growths. This could potentially lead to earlier and more accurate detection of breast cancer, providing an edge over existing screening techniques. By integrating CEM into the regular screening schedule, researchers hope to enhance the effectiveness of breast cancer screening and improve patient outcomes.

What evidence suggests that contrast-enhanced mammography is effective for breast cancer detection?

Research has shown that contrast-enhanced mammography (CEM), which participants in this trial will receive, effectively detects breast cancer. Studies have found CEM to be more accurate than regular mammograms and ultrasounds, particularly for women with dense breast tissue. This method uses a special dye to highlight blood vessels, aiding in early cancer detection. Early results suggest that CEM can identify cancer more effectively without causing many false alarms. Overall, CEM is a promising tool for breast cancer screening, enhancing detection accuracy. ^{1 2 3 5 6}

Who Is on the Research Team?

Wendie Berg, MD, PhD

Principal Investigator

University of Pittsburgh

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Contrast-enhanced mammography

Trial Overview 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.

How Is the Trial Designed?

Group I: contrast-enhanced mammography Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

Wendie Berg

Lead Sponsor

Trials

4

Recruited

10,000+

Breast Cancer Research Foundation

Collaborator

Trials

79

Recruited

40,500+

Published Research Related to This Trial

Dual-energy contrast-enhanced mammography (CESM) is a promising new imaging technique for breast cancer that aims to overcome the limitations of traditional methods like MRI and CT, which can be expensive and expose patients to high radiation doses.

The review highlights both the advantages of CESM, such as improved imaging capabilities, and its drawbacks, indicating a need for further research to optimize its use in breast care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dual-energy contrast-enhanced spectral mammography (CESM). Daniaux, M., De Zordo, T., Santner, W., et al.[2018]

In a study of 839 women recalled from breast cancer screening, contrast-enhanced spectral mammography (CESM) detected 70 lesions that were not identified by standard methods, with over half (54.3%) of these lesions being malignant, primarily invasive ductal carcinomas.

CESM demonstrated a low risk profile, with only five minor adverse reactions reported and a median radiation dose of 6.0 mGy per exam, suggesting it is a safe and effective tool for further evaluation in breast cancer screening.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Contrast-enhanced spectral mammography as work-up tool in patients recalled from breast cancer screening has low risks and might hold clinical benefits. Houben, IPL., Van de Voorde, P., Jeukens, CRLPN., et al.[2018]

Contrast-enhanced spectral mammography (CESM) significantly improves diagnostic accuracy in breast cancer detection, achieving a sensitivity of 96.9% and a specificity of 69.7% across a diverse group of radiologists.

The study confirms that CESM is superior to conventional mammography, providing excellent problem-solving capabilities for women referred from breast cancer screening programs, regardless of the radiologists' experience levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Contrast-enhanced spectral mammography in recalls from the Dutch breast cancer screening program: validation of results in a large multireader, multicase study. Lalji, UC., Houben, IP., Prevos, R., et al.[2020]

Low-energy contrast-enhanced spectral mammography (CESM) images are comparable in quality to full-field digital mammograms (FFDM), with no significant differences in 17 out of 20 evaluated criteria, suggesting that CESM can be a reliable alternative.

LE CESM provides better visualization of micro-calcifications compared to FFDM, indicating its potential advantage in detecting certain breast abnormalities, despite no clear physical explanation for this improvement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of low-energy contrast-enhanced spectral mammography images by comparing them to full-field digital mammography using EUREF image quality criteria. Lalji, UC., Jeukens, CR., Houben, I., et al.[2020]

Contrast-enhanced spectral mammography (CESM) shows high diagnostic accuracy for breast cancer, with a pooled sensitivity of 89% and specificity of 84% based on a meta-analysis of 18 studies.

The diagnostic odds ratio for CESM is 71.36, indicating it is a reliable tool for the initial assessment of breast lesions, making it a valuable option in breast cancer diagnosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diagnostic Value of Contrast-Enhanced Spectral Mammography for Screening Breast Cancer: Systematic Review and Meta-analysis. Zhu, X., Huang, JM., Zhang, K., et al.[2019]

Contrast-enhanced spectral mammography (CESM) significantly improves diagnostic accuracy compared to conventional mammography, achieving 100% sensitivity and 87.7% specificity in a study of 113 women referred from a breast cancer screening program.

CESM not only outperforms mammography in detecting breast cancer but also shows comparable results to MRI and histopathology in assessing the extent of cancer, making it a valuable tool even in populations with lower disease prevalence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Contrast-enhanced spectral mammography in patients referred from the breast cancer screening programme. Lobbes, MB., Lalji, U., Houwers, J., et al.[2022]

In a study of 167 female patients, contrast-enhanced spectral mammography (CESM) was able to quantitatively assess contrast enhancement, revealing a significant correlation between the degree of enhancement and the malignancy of breast lesions.

The analysis showed that infiltrating cancers exhibited the highest enhancement values, while benign lesions had the lowest, indicating that CESM can effectively differentiate between invasive cancers and benign or non-invasive lesions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Correlation between quantitative assessment of contrast enhancement in contrast-enhanced spectral mammography (CESM) and histopathology-preliminary results. Rudnicki, W., Heinze, S., Niemiec, J., et al.[2020]

Contrast-enhanced spectral mammography (CESM) significantly improves the accuracy of breast cancer detection by reducing false-positive and false-negative results while maintaining high sensitivity.

The study highlights that many artifacts affecting image quality in CESM can be easily resolved, providing valuable insights for practitioners to enhance the effectiveness of this imaging technique.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Contrast-enhanced Spectral Mammography: Modality-Specific Artifacts and Other Factors Which May Interfere with Image Quality. Bhimani, C., Li, L., Liao, L., et al.[2018]

Contrast-enhanced spectral mammography (CESM) effectively combines digital mammography with tumor angiogenesis assessment, enhancing its utility in breast cancer detection.

CESM has been successfully integrated into clinical practice for various purposes, including screening, diagnosis, staging, and monitoring treatment response, highlighting its versatility in managing breast cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Contrast-enhanced Spectral Mammography: Technique, Indications, and Clinical Applications. Bhimani, C., Matta, D., Roth, RG., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10680079/

Contrast-Enhanced Mammography in Breast Cancer Screening Contrast-enhanced mammography (CEM) is a promising vascular-based breast imaging technique with high diagnostic performance in detecting breast cancer.

2. pubs.rsna.org pubs.rsna.org/doi/full/10.1148/radiol.2021201948

Contrast-enhanced Mammography: State of the Art CEM has been demonstrated to help improve accuracy compared with digital mammography and US in women with abnormal screening mammographic ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S0720048X25004371

Contrast-Enhanced Mammography: Bridging the research ... Interim results have demonstrated that supplemental contrast imaging facilitate earlier cancer detection in women with dense breasts, without significant ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05625659

Comparison of Breast Cancer Screening With CESM to ... Aim 2: To evaluate the performance of CESM compared to DBT at the 1-year follow up for breast-cancer screening in women with dense breasts. Detailed Description.

5. thelancet.com thelancet.com/journals/lanepe/article/PIIS2666-7762(24)00154-6/fulltext

a multicentre, open-label, randomised controlled clinical trial Contrast-enhanced mammography versus conventional imaging in women recalled from breast cancer screening (RACER trial): a multicentre, open-label, randomised ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11674923/

Contrast-Enhanced Mammography: A Literature Review of ... Contrast-enhanced mammography (CEM) is a modern mammographic examination simultaneously using low- and high-energy exposures after the administration of ...