1000 Participants Needed

Contrast Enhanced Mammography for Breast Cancer

OW
Overseen ByOlena Weaver, MD
Age: 18+
Sex: Female
Trial Phase: Academic
Sponsor: M.D. Anderson Cancer Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a new imaging method, Contrast-Enhanced Mammography (CEM), can detect breast cancer more effectively than regular mammograms in women with dense breasts. Dense breast tissue can make cancer detection more challenging with traditional mammograms. Women with dense breasts who regularly undergo mammograms might be suitable candidates for this study. The goal is to enhance cancer detection and help women better understand their breast cancer risk.

As a Phase 2 trial, this research measures CEM's effectiveness in an initial, smaller group, providing participants an opportunity to contribute to advancements in breast cancer detection.

Do I have to stop taking my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on imaging technology, so it's unlikely that your medications will be affected, but you should confirm with the trial coordinators.

What prior data suggests that Contrast-Enhanced Mammography is safe for detecting breast cancers in women with dense breasts?

Research has shown that Contrast-Enhanced Mammography (CEM) is generally safe for patients. Studies indicate that only about 0.007% of patients experience a reaction to the contrast dye. This means that out of 10,000 people, fewer than one person might have a reaction. The FDA has approved the contrast dye used in CEM, called Ultravist® (iopromide), confirming its thorough safety testing. However, like any medical procedure, there are some risks, such as slightly increased radiation exposure compared to standard mammography. Overall, CEM is considered safe and well-tolerated for most women.12345

Why are researchers excited about this trial?

Contrast Enhanced Mammography (CEM) is unique because it offers a more detailed imaging technique for breast cancer screening, especially in women with dense breast tissue. Unlike traditional mammography, which sometimes struggles to differentiate between dense tissue and potential tumors, CEM uses a contrast agent that highlights areas of increased blood flow, often associated with cancerous tissues. This enhanced visibility can lead to earlier and more accurate detection of breast cancer, which is why researchers are excited about its potential to improve screening outcomes.

What evidence suggests that Contrast-Enhanced Mammography is effective for detecting breast cancers in women with dense breasts?

Research has shown that Contrast-Enhanced Mammography (CEM), which participants in this trial will undergo, helps detect breast cancers more effectively in women with dense breast tissue. One study found that CEM increased cancer detection to 87.5%, compared to 50% with regular mammography. Another study reported that CEM detected cancer in 13.1 out of every 1,000 cases. Adding CEM to other imaging methods significantly improved early detection of breast cancer. These findings suggest that CEM is a useful tool for screening breast cancer in women with dense breasts.678910

Who Is on the Research Team?

OW

Olena Weaver, MD

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

Inclusion Criteria

Female patients 30-75 years of age with dense breasts (ACR BI-RADS categories C and D) who undergo routine yearly mammography at participating MDACC sites
Willingness to co-enroll or currently enrolled in PA17-0584
Willingness to participate in the study and ability to provide informed consent

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging

Participants undergo contrast-enhanced mammography for breast cancer screening

Ongoing
1 visit (in-person)

Data Collection

Collection of imaging, clinical data, health measurements, and questionnaire data

Ongoing

Follow-up

Participants are monitored for safety and effectiveness after imaging

6 months

What Are the Treatments Tested in This Trial?

Interventions

  • CEM
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Contrast Enhanced MammographyExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials
3,107
Recruited
1,813,000+

Citations

Contrast-Enhanced Mammography in Breast Cancer ScreeningCEM improved the sensitivity of standard 2D mammography (87.5% vs 50.0%, p = 0.03) with an incremental cancer detection rate of 6.6 per 1000 women. The overall ...
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 ...
Evaluating ten years of breast cancer screening with ...The cancer detection rate for CEM was 13.1 per 1,000 cases, and the AUC was 0.923. Conclusions. CEM is a viable breast cancer screening method for women with ...
Contrast-enhanced Mammography in Women With a ...This study aims to assess the effectiveness of Contrast-Enhanced Mammography (CEM)as an alternative to traditional ultrasound for breast cancer screening in ...
Contrast-enhanced mammography for breast cancer ...CEM with HCCM provides excellent diagnostic performance, achieving high sensitivity and specificity while allowing for a reduced iodine dose and increased IDR.
Contrast-enhanced Mammography: State of the ArtContrast-enhanced mammography is an emerging breast imaging modality that helps improve diagnostic accuracy when routine breast imaging produces inconclusive ...
Contrast-enhanced mammography: what the radiologist ...Contrast-enhanced mammography (CEM) is a combination of standard mammography and iodinated contrast material administration.
Contrast-Enhanced Mammography: Bridging the research ...For what concerns contrast agent safety, adverse reactions were reported by 17 % studies (0.007 % patients) included in the systematic review by Zanardo et at.
Contrast enhanced mammographyUltravist® (iopromide) injection is the first and only iodinated contrast agent FDA approved for intravenous use with contrast-enhanced mammography to visualize ...
Barriers to Implementation of Contrast-Enhanced ...These factors include the risks related to the use of iodinated contrast agents, increased radiation exposure, indications for which CEM is not the preferred ...
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