CESM vs DBT Screening for Dense Breasts in Breast Cancer Detection

(CMIST Trial)

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: American College of Radiology

Must not be taking: Metformin

Disqualifiers: Breast cancer, High-risk lesions, others

No Placebo Group

Approved in 3 Jurisdictions

Trial Summary

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 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.

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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.

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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.

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Eligibility Criteria

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.

Trial Timeline

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

Participant Groups

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.

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

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Carolina Breast Imaging Specialists Greenville, NC

Who Is Running the Clinical Trial?

American College of Radiology Lead Sponsor

Breast Cancer Research Foundation Collaborator

GE Healthcare Industry Sponsor

References

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

Dual-energy contrast-enhanced spectral mammography (CESM). [2018] Dual-energy contrast-enhanced mammography is one of the latest developments in breast care. Imaging with contrast agents in breast cancer was already known from previous magnetic resonance imaging and computed tomography studies. However, high costs, limited availability-or high radiation dose-led to the development of contrast-enhanced spectral mammography (CESM). We reviewed the current literature, present our experience, discuss the advantages and drawbacks of CESM and look at the future of this innovative technique.

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] Contrast-enhanced spectral mammography (CESM) is a new image examination technology that has developed over the past few years. As CESM technology keeps improving, a current meta-analysis review is needed to systematically evaluate the potential diagnostic value of CESM.

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] Contrast-enhanced spectral mammography (CESM) is a promising problem-solving tool in women referred from a breast cancer screening program. We aimed to study the validity of preliminary results of CESM using a larger panel of radiologists with different levels of CESM experience.

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] Contrast-enhanced spectral mammography (CESM) is a reliable problem solving tool in the work-up of women recalled from breast cancer screening. We evaluated additional findings caused by CESM alone and outweighed them against the disadvantages of this technique.

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] To evaluate the diagnostic performance of contrast-enhanced dual-energy spectral mammography (CESM) in comparison with that of full-field digital mammography (FFDM), either alone or accompanied with breast ultrasound (BUS) in a large series of patients/breast lesions (n = 644).

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

Can Contrast-Enhanced Spectral Mammography (CESM) Reduce Benign Breast Biopsy? [2022] To evaluate the potential of contrast-enhanced spectral mammography (CESM) in reducing benign breast biopsy rate, thereby improving resource utilization. To explore its potential as a value-adding modality in the management of BI-RADS 4/5 lesions.

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] Contrast-enhanced spectral mammography (CESM) uses full field digital mammography with the added benefit of intravenous contrast administration to significantly reduce false-positive and false-negative results and improve specificity while maintaining high sensitivity. For CESM to fulfill its purpose, one should be aware of possible artifacts and other factors which may interfere with image quality, and attention should be taken to minimize these factors.

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

Contrast-Enhanced Spectral Mammography in Women With Intermediate Breast Cancer Risk and Dense Breasts. [2021] The purpose of this study was to compare the diagnostic performance of contrast-enhanced spectral mammography (CESM) and ultrasound with that of standard digital mammography for breast cancer screening of women at intermediate risk who have dense breasts.