CESM vs DBT Screening for Dense Breasts in Breast Cancer Detection

(CMIST Trial)

Overseen By Etta Pisano, MD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: American College of Radiology

Must not be taking: Metformin

Disqualifiers: Breast cancer, High-risk lesions, 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: 2

2032 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The over-arching goal of the Contrast-Enhanced Spectral Mammography Imaging Screening Trial (CMIST) is to determine if dual-energy contrast-enhanced spectral mammography (CESM) can detect more cancers with fewer false positives than digital breast tomosynthesis (DBT) in women with dense breasts. Aim 1: To evaluate the performance of CESM compared to DBT at baseline for breast-cancer screening in women with dense breasts. 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.

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

The trial protocol does not specify if you need to stop taking your current medications. However, if you are using metformin or metformin-containing drugs, you may need to discuss this with the trial team due to potential renal impairment concerns.

What safety data exists for CESM in breast cancer detection?

The safety data for CESM indicates that it is a reliable tool with low risks when used in breast cancer screening. It is considered a problem-solving tool with potential clinical benefits, and it can reduce false-positive and false-negative results. However, attention should be given to modality-specific artifacts and factors that may interfere with image quality. ^{1 2 3 4 5}

Is Dual-Energy Contrast-Enhanced Spectral Mammography (CESM) a promising treatment for detecting breast cancer in women with dense breasts?

Yes, CESM is a promising treatment for detecting breast cancer, especially in women with dense breasts. It has shown good diagnostic performance and is considered a valuable tool in breast cancer screening programs. ^{1 3 6 7 8}

What data supports the idea that CESM vs DBT Screening for Dense Breasts in Breast Cancer Detection is an effective treatment?

The available research shows that Contrast-Enhanced Spectral Mammography (CESM) is a promising tool for detecting breast cancer, especially in women with dense breast tissue. Studies indicate that CESM is reliable and can help solve problems when women are called back for further screening after an initial test. It has been found to have low risks and potential benefits, making it a useful option. Compared to traditional methods like full-field digital mammography, CESM has shown good diagnostic performance, meaning it can effectively identify breast cancer. This suggests that CESM is an effective treatment for screening dense breasts in breast cancer detection. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

This trial is for women with dense breasts who can have an IV contrast (no allergies to iodine or severe reactions to allergens), are not pregnant or breastfeeding, and do not have symptoms of breast disease. They must agree to avoid certain breast screenings and use effective contraception during the trial.

Inclusion Criteria

I do not have any breast symptoms like lumps or unusual discharge.

I am not pregnant or breastfeeding and have confirmed this with a test if necessary.

I can safely receive IV contrast for scans without allergic reactions.

Exclusion Criteria

I had a mammogram less than 11 months ago.

I am not pregnant, breastfeeding, nor planning to become pregnant soon.

I am currently being treated for breast cancer or planning surgery for a high-risk breast lesion.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Imaging

Baseline imaging with DBT and CESM performed on the same day for women with dense breasts

1 day

1 visit (in-person)

1-Year Follow-up Imaging

Standard DBT and CESM screening views performed 12 months after baseline imaging

1 day

1 visit (in-person)

2-Year Follow-up

Participants contacted to confirm no interval breast cancer diagnosis and asked about adverse events

12 months

Contact via email, text, or phone

What Are the Treatments Tested in This Trial?

Interventions

• Dual-Energy Contrast-Enhanced Spectral Mammography (CESM)

Trial Overview The CMIST study is testing if CESM detects more cancers with fewer false positives than DBT in women with dense breasts. It compares the two methods at initial screening and again after one year.

How Is the Trial Designed?

Group I: DBT and CESM Diagnostic Imaging in Women with Dense Breasts Experimental Treatment 1 Intervention

Interventional Diagnostic

Dual-Energy Contrast-Enhanced Spectral Mammography (CESM) is already approved in United States, Canada, European Union for the following indications:

Approved in United States as Contrast-Enhanced Spectral Mammography for:

• Breast cancer screening in women with dense breasts

Approved in Canada as Contrast-Enhanced Spectral Mammography for:

• Breast cancer screening in women with dense breasts

Approved in European Union as Contrast-Enhanced Spectral Mammography for:

• Breast cancer screening in women with dense breasts

Who Is Running the Clinical Trial?

American College of Radiology

Lead Sponsor

Trials

24

Recruited

8,055,000+

Breast Cancer Research Foundation

Collaborator

Trials

79

Recruited

40,500+

GE Healthcare

Industry Sponsor

Trials

307

Recruited

634,000+

Fotis Vlachos

GE Healthcare

Chief Marketing Officer since 2024

PhD in Molecular Biology and Biochemistry from the University of Massachusetts, MBA from the Wharton School of the University of Pennsylvania

Peter J. Arduini

GE Healthcare

Chief Executive Officer since 2022

MBA from Northwestern University, BSc in Marketing from Susquehanna University

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]

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 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]

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 dual-energy spectral mammography (CESM) demonstrated high diagnostic accuracy, identifying 93% of malignant lesions and 85% of benign lesions in a study of 644 breast lesions, significantly outperforming full-field digital mammography (FFDM) and FFDM combined with breast ultrasound (BUS).

CESM improved sensitivity, specificity, and positive predictive value compared to FFDM and FFDM+BUS, with a sensitivity increase of 10.7% and 3.4% respectively, indicating it is a valuable tool for breast lesion assessment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diagnostic performance of contrast-enhanced dual-energy spectral mammography (CESM): a retrospective study involving 644 breast lesions. Travieso-Aja, MDM., Maldonado-Saluzzi, D., Naranjo-Santana, P., et al.[2019]

Contrast-enhanced spectral mammography (CESM) can significantly reduce the rate of benign breast biopsies by accurately identifying benign lesions, particularly in cases classified as BI-RADS 4A, where 20.9% showed no enhancement and were confirmed benign.

CESM not only helps in reducing unnecessary biopsies but also increases the detection of malignant lesions, identifying 6 additional suspicious lesions that conventional imaging missed, thus potentially changing treatment strategies for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can Contrast-Enhanced Spectral Mammography (CESM) Reduce Benign Breast Biopsy? Liew, ALF., Lim, HMY., Fok, ECM., 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) demonstrated significantly higher sensitivity (90.5%) compared to standard digital mammography (52.4%) for detecting breast cancer in women with dense breasts, indicating it may be a more effective screening tool.

The study found no additional benefit from using ultrasound alongside CESM, as all additional findings from ultrasound were false positives, suggesting that CESM alone could be sufficient for screening in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Contrast-Enhanced Spectral Mammography in Women With Intermediate Breast Cancer Risk and Dense Breasts. Sorin, V., Yagil, Y., Yosepovich, A., et al.[2021]

Citations

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

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

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

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

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. 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]

5. Italy pubmed.ncbi.nlm.nih.gov

Diagnostic performance of contrast-enhanced dual-energy spectral mammography (CESM): a retrospective study involving 644 breast lesions. [2019]

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

Can Contrast-Enhanced Spectral Mammography (CESM) Reduce Benign Breast Biopsy? [2022]

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

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

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

Contrast-Enhanced Spectral Mammography in Women With Intermediate Breast Cancer Risk and Dense Breasts. [2021]