Biennial CEM Screening for Breast Cancer

Recruiting at 4 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

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. ^{1 2 3 4 5}

Is 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. ^{3 4 6 7 8}

How 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. ^{1 3 4 7 9}

Research Team

Wendie Berg, MD, PhD

Principal Investigator

University of Pittsburgh

Eligibility 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.

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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) 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]

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) 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]

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]

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]

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]

References

1. Germany 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. [2020]

2. Germany pubmed.ncbi.nlm.nih.gov

Contrast-enhanced spectral mammography in patients referred from the breast cancer screening programme. [2022]

3. Ireland 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. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

Diagnostic Value of Contrast-Enhanced Spectral Mammography for Screening Breast Cancer: Systematic Review and Meta-analysis. [2019]

5. Germany pubmed.ncbi.nlm.nih.gov

Correlation between quantitative assessment of contrast enhancement in contrast-enhanced spectral mammography (CESM) and histopathology-preliminary results. [2020]

6. United States pubmed.ncbi.nlm.nih.gov

Contrast-enhanced Spectral Mammography: Technique, Indications, and Clinical Applications. [2022]

7. Germany pubmed.ncbi.nlm.nih.gov

Dual-energy contrast-enhanced spectral mammography (CESM). [2018]

8. United States pubmed.ncbi.nlm.nih.gov

Contrast-enhanced Spectral Mammography: Modality-Specific Artifacts and Other Factors Which May Interfere with Image Quality. [2018]

9. Germany 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. [2020]