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

50 Participants Needed

Trial Summary

What is the purpose of this trial?

This study aims to assess the effectiveness of Contrast-Enhanced Mammography (CEM)as an alternative to traditional ultrasound for breast cancer screening in women with dense breasts and a personal history of breast cancer. CEM combines standard mammography with a contrast agent to better detect tumors, particularly in women with dense tissue where traditional mammograms may miss signs of cancer. The study will compare CEM with ultrasound and MRI to determine its accuracy in detecting cancer, reduce wait times for screening, and provide a more affordable option than MRI. Women who participate will have their screening done in one visit, improving convenience and access. The study will track cancer detection rates, biopsy results, and patient satisfaction over two years to evaluate the benefits of CEM for early breast cancer detection.

Research Team

Dr. Jean Seely Principal Investigator,, MD FRCPC

Principal Investigator

Ottawa Hospital Research Institute

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+