Contrast-Enhanced Mammography for Breast Cancer Screening

(SCEMAM Trial)

No longer 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method for breast cancer screening using contrast-enhanced mammography (CEM). The researchers aim to determine if CEM can serve as a viable alternative to MRI for women unable to undergo MRI due to factors like body size, pacemakers, or cost. Suitable candidates for this trial include women at high risk for breast cancer who have been advised to get an MRI but cannot for these reasons. This group includes women with dense breast tissue or a strong family history of breast cancer. As a Phase 4 trial, the research focuses on understanding how this FDA-approved and effective screening method can benefit more patients.

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 is the safety track record for contrast-enhanced mammography and iodinated contrast media?

Research shows that contrast-enhanced mammography (CEM) is generally easy for patients to handle. Studies have found that CEM can be a reliable option for breast cancer screening, especially for those unable to undergo an MRI. This method uses a special dye, similar to that used in CT scans, and involves taking pictures with updated mammography machines.

Most people experience few side effects. Some might feel a warm sensation or develop a slight rash from the dye, but serious reactions are rare. This method has been used and studied for detecting breast cancer, proving it to be relatively safe and effective. Those with concerns about allergies or reactions to the dye should consult their doctor. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about contrast-enhanced mammography because it offers a new way to screen for breast cancer, especially for women who can't access MRI due to medical, access, or cost reasons. Unlike traditional mammography or tomosynthesis, this technique uses a contrast agent to highlight blood vessels in breast tissue, potentially making it easier to detect tumors. This could be particularly beneficial for women with dense breast tissue, where standard mammography might miss abnormalities. By providing an alternative to MRI that is more accessible, contrast-enhanced mammography could improve early detection and outcomes for many women.

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

Studies have shown that contrast-enhanced mammography (CEM), which participants in this trial may receive, effectively detects breast cancer. Research indicates that CEM can help find cancers earlier, particularly in women with dense breast tissue. One study found that combining CEM with standard imaging increased early cancer detection by 13%. CEM uses a special dye to make blood vessels in the breast more visible, aiding in tumor detection. Overall, CEM is a promising tool for breast cancer screening, especially for those unable to undergo an MRI. ^{2 3 6 7 8}

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 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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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) 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]

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]

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) 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 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]

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) 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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8018270/

The effectiveness of contrast-enhanced spectral ... Mammography remains the standard method in breast cancer diagnostics. Despite the development of different diagnostic methods, only mammographic sensitivity and ...

2. 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 ...

3. 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.

4. pubs.rsna.org pubs.rsna.org/doi/10.1148/radiol.242634

Screening for Breast Cancer with Contrast-enhanced ... Adding contrast-enhanced mammography to digital breast tomosynthesis significantly increased early breast cancer detection alongside a 13% increase in the ...

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

Contrast-enhanced Mammography: State of the Art Contrast-enhanced mammography is an emerging breast imaging modality that helps improve diagnostic accuracy when routine breast imaging produces inconclusive ...

7. 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.

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

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