Contrast-Enhanced Mammography for Breast Cancer Screening

(SCEMAM Trial)

Recruiting at 2 trial locations

Overseen By McKenna Rigling, BS

Age: 18+

Sex: Female

Trial Phase: Phase 4

Sponsor: Wendie Berg

Must not be taking: Systemic chemotherapy

Disqualifiers: Under 30, Over 75, Pregnant, Breastfeeding, Breast implants, Recent breast surgery, Breast symptoms, Reduced kidney function, others

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

Prior Safety Data This treatment has passed at least one previous human trial

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

Compensation: Varies

Number of Visits: Unknown

Duration: 1.5 years

601 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing contrast-enhanced mammography (CEM) as an alternative for women who need a breast MRI but can't get one. CEM uses a special dye with regular mammogram machines to make cancer spots more visible. The goal is to improve breast cancer detection in women who can't have an MRI. CEM combines conventional mammography with iodinated contrast material to improve cancer detection.

Do I need to stop my current medications for the trial?

The trial does not specify if you need to stop taking your current medications. However, if you are undergoing systemic chemotherapy, you cannot participate in the trial. Oral endocrine therapies like aromatase inhibitors or tamoxifen are allowed.

What data supports the effectiveness of the treatment Contrast-enhanced mammography for breast cancer screening?

Research shows that contrast-enhanced spectral mammography (CESM) improves the accuracy of breast cancer screening by reducing false-positive and false-negative results, making it a promising tool for detecting breast cancer more reliably. ^{1 2 3 4 5}

How is contrast-enhanced mammography different from other breast cancer screening treatments?

Contrast-enhanced mammography (CEM) is unique because it combines traditional mammography with a contrast agent to highlight blood vessels in the breast, which can help detect tumors more effectively. This method is less expensive and more accessible than other imaging techniques like MRI, while still providing detailed images that can improve cancer detection. ^{2 4 6 7 8}

Research Team

Wendie Berg, MD, PhD

Principal Investigator

University of Pittsburgh

Eligibility Criteria

This trial is for women aged 30-75 with dense breasts or high breast cancer risk due to genetics, family history, or past chest radiation. It's also for those recommended for MRI screening but can't have it due to factors like claustrophobia or implants. Women with a personal history of early breast cancer are eligible too. Exclusions include current breast symptoms, poor kidney function, active chemotherapy (except oral endocrine therapy), having breast implants, being under 30 or over 75 years old, and recent pregnancy/breastfeeding or breast surgery.

Inclusion Criteria

Women aged 40-75 with very dense breasts.

You have a high risk of breast cancer due to genetic mutations, past radiation therapy to the chest before the age of 30, or a strong family history of breast cancer.

Women under 75 years old who are advised to have yearly MRI and mammogram screenings based on current guidelines.

Exclusion Criteria

You have noticeable breast changes like a lump, nipple discharge, or nipple retraction, or you have been getting checked for a breast abnormality.

Your kidneys are not working well, with an eGFR less than 45 mL/min.

You are currently receiving treatment for cancer with chemotherapy, but not with oral hormone therapy like aromatase inhibitors or tamoxifen.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo contrast-enhanced mammography (CEM) as an alternative to MRI for breast cancer screening

1.5 years

Visits as per standard-of-care mammography/tomosynthesis schedule

Follow-up

Participants are monitored for cancer detection rates and false positive recall rates

1.5 years

Treatment Details

Interventions

• Contrast-enhanced mammography
• Iodinated Contrast Media (ICM)

Trial Overview The study tests if contrast-enhanced mammography (CEM) can be an alternative to MRI for breast cancer screening in women who cannot undergo MRI. CEM uses standard mammography equipment plus an intravenous iodinated contrast agent similar to what's used in CT scans.

Participant Groups

Group I: Contrast-enhanced mammography Experimental Treatment 2 Interventions

Women who meet criteria for supplemental screening MRI, but who are unable to have MRI for medical/access/cost reasons, will be invited to have screening with contrast-enhanced mammography. Women will also have standard-of-care mammography/tomosynthesis per usual clinical practice.

Contrast-enhanced mammography is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as CEM for:

• Breast cancer screening
• Preoperative staging of breast cancer
• Monitoring response to neoadjuvant chemotherapy

Approved in United States as CEM for:

• Breast cancer screening in women with dense breasts or high risk
• Preoperative staging of breast cancer
• Monitoring response to neoadjuvant chemotherapy

Approved in Canada as CEM for:

• Breast cancer screening in women with dense breasts or high risk
• Preoperative staging of breast cancer
• Monitoring response to neoadjuvant chemotherapy

Who Is Running the Clinical Trial?

Wendie Berg

Lead Sponsor

Trials

4

Recruited

10,000+

PA Breast Cancer Coalition

Collaborator

Trials

1

Recruited

600+

Findings from Research

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]

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 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) 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]

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]

Dual-energy contrast-enhanced spectral mammography (DE-CESM) effectively enhances the diagnosis of suspicious malignant microcalcifications, showing a high diagnostic sensitivity of 90.9% and specificity of 83.78% based on a study of 59 cases with pathological diagnoses.

The method also provides accurate measurements of cancer size, with a mean difference of only 0.05 cm compared to surgical histology, indicating its reliability for evaluating breast cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical utility of dual-energy contrast-enhanced spectral mammography for breast microcalcifications without associated mass: a preliminary analysis. Cheung, YC., Tsai, HP., Lo, YF., 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]

References

1. Germany pubmed.ncbi.nlm.nih.gov

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

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

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

3. 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]

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

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

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

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

6. Germany pubmed.ncbi.nlm.nih.gov

Clinical utility of dual-energy contrast-enhanced spectral mammography for breast microcalcifications without associated mass: a preliminary analysis. [2020]

7. 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]

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

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