Contrast-Enhanced Mammography for Breast Cancer

Overseen By Ada Lo

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Allergy to iodine, Renal insufficiency, Pregnancy, others

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

Approved in 5 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

151 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how well contrast-enhanced mammography (CEM) can identify serious breast conditions like ductal carcinoma in situ (DCIS) or invasive cancer. Regular mammograms often detect suspicious spots known as microcalcifications, which can sometimes be cancerous but often are not. The study aims to determine if CEM can better predict whether these microcalcifications are harmful. Women with suspicious microcalcifications who are planning a biopsy might be suitable for this trial. As a Phase 2 trial, this research focuses on measuring CEM's effectiveness in an initial, smaller group, offering participants a chance to contribute to important advancements in breast cancer detection.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that contrast-enhanced mammography is safe for predicting breast cancer?

Research has shown that contrast-enhanced mammography (CEM) combines regular mammograms with a special dye to detect breast cancer more effectively. Studies have found that CEM can identify cancers that standard mammograms might miss.

In terms of safety, CEM uses a dye that most people tolerate well. Some individuals might experience mild side effects like nausea or warmth, but serious reactions are rare. The radiation from CEM is slightly higher than that of regular mammograms, yet it remains within safe levels.

Overall, CEM is considered safe for most women. It is advisable to discuss any concerns with a doctor before participating in a study. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about contrast-enhanced mammography (CEM) because it offers a new way to evaluate mammographic microcalcifications. Unlike standard mammograms that rely solely on X-ray images, CEM uses a contrast agent to highlight areas of concern, potentially making it easier to differentiate between benign and suspicious calcifications. This enhanced imaging could lead to more accurate diagnoses and reduce the need for invasive biopsies. By improving the clarity of mammograms, CEM could become a valuable tool for early breast cancer detection and management.

What evidence suggests that contrast-enhanced mammography is effective for predicting high-grade ductal carcinoma in situ or invasive cancer?

Research has shown that contrast-enhanced mammography (CEM), which participants in this trial will undergo, effectively detects breast cancer, particularly in women with dense breast tissue. Studies have found that CEM is highly sensitive, accurately identifying those with the disease. It can detect cancers earlier in dense breasts without causing many false alarms. The FDA has already approved CEM as a reliable diagnostic tool. This imaging method may help distinguish between harmless (non-cancerous) and harmful (cancerous) tiny calcium deposits, reducing unnecessary follow-up tests. ^{2 6 7 8 9}

Who Is on the Research Team?

Olena Weaver

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

Inclusion Criteria

Women with suspicious mammographic microcalcifications (Breast Imaging Reporting and Data System [BI-RADS] categories 4 or 5) occupying an area equal to or exceeding 4 cm in diameter and recommended for a stereotactic biopsy, who underwent their diagnostic imaging work-up resulting in a biopsy recommendation at MD Anderson Cancer Center (MDACC) or at an outside facility with a technically acceptable quality of diagnostic mammography, and who are planning to have their stereotactic biopsy at MDACC.

Age 25-85 years

Willing to participate in the study, undergo an intravenous (IV) placement, able to undergo iodinated contrast injection, and able to provide informed consent

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Diagnostic

Patients complete a questionnaire, undergo collection of a blood sample, and receive contrast intravenously for contrast-enhanced mammography (CEM).

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after diagnostic procedures

24 months

What Are the Treatments Tested in This Trial?

Interventions

• Biospecimen Collection
• Contrast Agent
• Contrast-Enhanced Mammography

How Is the Trial Designed?

Group I: Diagnostic (contrast-enhanced mammography) Experimental Treatment 4 Interventions

Patients complete a questionnaire and undergo collection of a blood sample. Patients undergo CEM.

Contrast-Enhanced Mammography is already approved in European Union, United States, China for the following indications:

Approved in European Union as CEM for:

• Breast cancer detection
• Preoperative staging
• Neoadjuvant chemotherapy response assessment

Approved in United States as CEM for:

• Breast cancer detection
• Supplemental screening in dense breasts

Approved in China as CEM for:

• Breast cancer detection
• Preoperative staging

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

Citations

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

The effectiveness of contrast-enhanced spectral ... Our study showed that CESM is a great diagnostic tool not only for patients with fatty type breast but also for those with glandular type. Therefore, MRI 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. densebreast-info.org densebreast-info.org/screening-technologies/contrast-enhanced-mammography/

Contrast-Enhanced Mammography (CEM) | DenseBreast ... CEM is FDA-approved for diagnostic breast imaging, and is proven effective ... contrast-enhanced spectral mammography into a breast imaging ...

4. pubs.rsna.org pubs.rsna.org/doi/abs/10.1148/radiol.232580

Diagnostic Accuracy of Screening Contrast-enhanced ... Conclusion. Compared with LE imaging, CEM showed higher sensitivity but lower specificity in female patients with extremely dense breasts, ...

5. bmjopen.bmj.com bmjopen.bmj.com/content/14/9/e069788

Meta-analysis and systematic review of the diagnostic ... The CESM has high sensitivity and good specificity when it comes to evaluating breast cancer, particularly in women with dense breasts.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8611680/

Contrast-enhanced mammography: what the radiologist ... Contrast-enhanced mammography (CEM) is a combination of standard mammography and iodinated contrast material administration.

7. 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 ...

8. ajronline.org ajronline.org/doi/10.2214/AJR.22.28567

Barriers to Implementation of Contrast-Enhanced ... The risks of both iodinated contrast agents and GBCAs must be considered when selecting between CEM and breast MRI in individual patients. · The radiation dose ...

9. radiologysolutions.bayer.com radiologysolutions.bayer.com/breast-imaging/contrast-enhanced-mammography

Contrast enhanced mammography Avoid blood remaining in contact with syringes containing iodinated contrast agents, which increases the risk of clotting. ... Contrast-enhanced spectral ...