Contrast-Enhanced Mammography for Breast Cancer

(CEM Trial)

Overseen By Dr. Jean Seely Department of Radiology, Radiation Oncology, MD, FRCPC, MD, FRCPC

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Jean Seely

Disqualifiers: Renal insufficiency, Contrast allergy, Thyroid disease, others

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

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines a new method for screening breast cancer in women with dense breast tissue and a personal history of breast cancer. It employs Contrast-Enhanced Mammography (CEM), which combines a regular mammogram with a special dye to detect tumors that traditional methods might miss. The trial aims to determine if CEM outperforms ultrasound and MRI by evaluating its cancer detection rate and patient satisfaction. Women with dense breasts and a clean mammogram, who are awaiting further screening, may be suitable candidates for this trial. As an unphased trial, it offers a unique opportunity to contribute to innovative screening methods that could enhance early detection for many women.

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

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 breast cancer screening?

Research shows that Contrast-Enhanced Mammography (CEM) is generally safe and well-tolerated. CEM uses a special dye to enhance tumor visibility during breast cancer screening. Studies have found that CEM is highly effective at detecting cancer, with accuracy rates between 89% and 97.7%, and it correctly identifies non-cancerous cases 50% to 89% of the time. This makes CEM particularly effective for women with dense breast tissue.

While studies primarily focus on CEM's cancer detection capabilities, they report very few side effects, suggesting CEM is safe for most people. The use of contrast dyes is common in medical imaging, and serious side effects are rare. However, mild reactions like warmth or a metallic taste can occur. Those concerned about dye allergies should consult a doctor before joining a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Contrast-Enhanced Mammography (CEM) is unique because it combines standard mammography with an iodinated contrast medium to enhance the visualization of breast lesions. This is particularly beneficial for women with dense breast tissue, where traditional mammograms might miss some cancers. Researchers are excited about CEM because it has the potential to improve cancer detection rates and reduce false positives, leading to more accurate diagnosis and fewer unnecessary biopsies.

What evidence suggests that Contrast-Enhanced Mammography is effective for breast cancer screening?

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 correctly identifies all cancer cases in dense breasts. Compared to traditional ultrasound, CEM and a shorter version of breast MRI detect three times more invasive cancers. Adding CEM to regular screenings significantly enhances early cancer detection. This evidence suggests that CEM is a powerful tool for early breast cancer screening, offering better visibility of tumors and reducing missed cases. ^{2 3 6 7 8}

Who Is on the Research Team?

Dr. Jean Seely Principal Investigator,, MD FRCPC

Principal Investigator

Ottawa Hospital Research Institute

Are You a Good Fit for This Trial?

This trial is for women with dense breast tissue who have had breast cancer before. It's testing if a special mammogram using contrast dye can find tumors better than usual methods. Women must be past their initial treatments and screenings to join.

Inclusion Criteria

I am a woman aged between 50 and 69.

My kidneys are healthy.

I am willing to sign consent and receive an IV contrast dye injection for the study.

Exclusion Criteria

Previous allergic reactions to Iodine-based contrast

Prior contrast allergy (CT contrast)

I have a thyroid condition.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 visit

1 visit (in-person)

Contrast-Enhanced Mammography

Participants undergo Contrast-Enhanced Mammography (CEM) as a supplemental screening method for breast cancer

1 visit

1 visit (in-person)

Follow-up

Participants are monitored for cancer detection rates, biopsy results, and patient satisfaction over two years

2 years

Procedure Safety Monitoring

Monitor and report any adverse events, including allergic reactions to the contrast medium and other side effects

3 years

What Are the Treatments Tested in This Trial?

Interventions

• Contrast-Enhanced Mammography

Trial Overview The study tests Contrast-Enhanced Mammography (CEM) against traditional ultrasound and MRI in detecting breast cancer. Participants will undergo CEM to see if it's more accurate, faster, and cost-effective for those with dense breasts.

How Is the Trial Designed?

Group I: **Contrast-Enhanced Mammography for Supplemental Breast Cancer Screening** Experimental Treatment 1 Intervention

This arm involves participants undergoing Contrast-Enhanced Mammography (CEM) as a supplemental screening method for breast cancer. CEM combines standard mammography with iodinated contrast medium to improve lesion visualization and tumor detection, particularly in women with dense breast tissue. Participants will receive CEM during a single visit at the Rose Ages Breast Health Centre, and their results will be evaluated for cancer detection, abnormal interpretation rates, and biopsy outcomes.

Who Is Running the Clinical Trial?

Jean Seely

Lead Sponsor

Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma

Industry Sponsor

Trials

28

Recruited

126,000+

Citations

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

The effectiveness of contrast-enhanced spectral ... Material analysis demonstrated both CESM and MRI sensitivity in dense breasts to be 100%. Until now, only the general sensitivity and specificity of both ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06993246

Contrast-enhanced Mammography in Women With a ... The primary outcome measure is the detection rate of breast cancer in women with dense breast tissue using contrast-enhanced mammography (CEM). The sensitivity ...

3. pubs.rsna.org pubs.rsna.org/doi/10.1148/radiol.242634

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 ...

4. thelancet.com thelancet.com/journals/lancet/article/PIIS0140-6736(25)00582-3/fulltext

Comparison of supplemental breast cancer imaging ... Abbreviated breast MRI and contrast-enhanced mammography detected three times as many invasive cancers than whole breast ultrasound. The ...

5. 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 ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10680079/

Contrast-Enhanced Mammography in Breast Cancer Screening The overall cancer detection rate was 15.5 per 1000 women, which is similar to MRI. Follow-up data for these patients are currently pending. Among a small ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0720048X24005230

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 ...

8. 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 ...