CESM vs DBT Screening for Dense Breasts in Breast Cancer Detection

(CMIST Trial)

Recruiting at 9 trial locations

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?

This trial aims to determine if dual-energy contrast-enhanced spectral mammography (CESM) detects breast cancer more effectively in women with dense breasts than standard digital breast tomosynthesis (DBT). Researchers hope CESM will identify more cancers with fewer false positives. Women with dense breast tissue and no current symptoms of breast disease might be suitable candidates. Participants must also be able to receive a special dye injection for the imaging process. As an unphased trial, this study allows participants to contribute to advancing breast cancer detection methods.

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 prior data suggests that CESM and DBT are safe for breast cancer screening in women with dense breasts?

Research has shown that dual-energy contrast-enhanced spectral mammography (CESM) is generally easy for patients to handle. Early results indicate that CESM can help detect cancer sooner in women with dense breast tissue, without causing major side effects.

Studies have found that CESM detects cancer with accuracy rates between 87.5% and 97.7%. This high accuracy is crucial for identifying potential problems and catching cancer early.

Overall, current evidence suggests that CESM is a promising and safe option for breast cancer screening in women with dense breasts. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Dual-Energy Contrast-Enhanced Spectral Mammography (CESM) for breast cancer detection in women with dense breasts because it offers a fresh approach compared to traditional methods like Digital Breast Tomosynthesis (DBT). CESM enhances contrast in mammography images by using a contrast agent, making it easier to spot abnormalities that might be missed in dense breast tissue. This technique could potentially lead to earlier and more accurate diagnosis, helping to improve outcomes for patients. Additionally, CESM may reduce the need for additional imaging, saving time and reducing anxiety for patients.

What evidence suggests that CESM is effective for breast cancer detection in women with dense breasts?

This trial will compare dual-energy contrast-enhanced spectral mammography (CESM) with digital breast tomosynthesis (DBT) for detecting breast cancer in women with dense breasts. Research has shown that CESM effectively detects breast cancer, particularly in women with dense breast tissue. Studies have found CESM to be as effective as MRI (magnetic resonance imaging) in cancer detection. CESM has a high accuracy rate of 89–97.7% for correctly identifying those with the disease and a specificity range of 50–89%, meaning it can correctly identify those without the disease. Previous comparisons have shown that CESM outperforms standard digital mammography in detecting breast cancer. Overall, CESM is a promising tool for screening women with dense breasts. ^{1 2 5 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

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]

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]

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

The effectiveness of contrast-enhanced spectral ... Conclusions. CESM can be used with confidence instead of MRI for cancer detection in patients with dense breast. It provides the same sensitivity as MRI, but ...

2. 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.

3. ajronline.org ajronline.org/doi/abs/10.2214/AJR.17.19355

Contrast-Enhanced Spectral Mammography in Women With ... CONCLUSION. CESM was significantly more sensitive than standard digital mammography for detecting breast cancer in this screening population. No added benefit ...

4. pubs.rsna.org pubs.rsna.org/doi/abs/10.1148/radiol.2019182660

Performance of Dual-Energy Contrast-enhanced Digital ... Conclusion. Contrast-enhanced digital mammography is a promising technique for screening women with higher-than-average risk for breast cancer.

5. tbcr.amegroups.org tbcr.amegroups.org/article/view/97517/html

Contrast-enhanced mammography in high-dense breasts CEM demonstrates high sensitivity (89–97.7%) and specificity (50–89%) in detecting malignancies within dense breasts, offering comparable diagnostic accuracy ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/25814297/

Dual-energy Contrast-Enhanced Spectral Mammography ... We reviewed the current literature, present our experience, discuss the advantages and drawbacks of CESM and look at the future of this innovative technique.

7. 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 ...