Contrast-enhanced Mammography in Women With a Personal History of Breast Cancer and Dense Breast Tissue: Benefit?

NCT ID: NCT06993246

Last Updated: 2025-05-28

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-15
• Study Completion Date: 2028-09-30

Brief Summary

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.

Detailed Description

Primary Outcome Measure: 1. Detection Rate of Breast Cancer The primary outcome measure is the detection rate of breast cancer in women with dense breast tissue using contrast-enhanced mammography (CEM). The sensitivity, specificity, and overall accuracy of CEM in detecting malignancies will be compared to conventional mammography and ultrasound.

Conditions

Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

**Contrast-Enhanced Mammography for Supplemental Breast Cancer Screening**

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.

Group Type: EXPERIMENTAL

Contrast-Enhanced Mammography (CEM)

Intervention Type: DIAGNOSTIC_TEST

The intervention involves the use of contrast-enhanced mammography (CEM) to supplement standard mammography for breast cancer screening. This method utilizes iodinated contrast medium to enhance the visualization of breast lesions by assessing tumor neovascularization. CEM will be offered to women with dense breast tissue who are currently awaiting supplemental ultrasound screening. It is designed to be performed in conjunction with regular mammography, offering a more efficient and cost-effective alternative to MRI, with comparable sensitivity in detecting breast cancer. Participants will undergo the CEM procedure in a single visit, allowing for reduced wait times and improved detection rates compared to traditional methods. The procedure is well-tolerated, with minimal side effects, and provides a quicker and more accessible option for supplemental breast cancer screening.

Interventions

Contrast-Enhanced Mammography (CEM)

The intervention involves the use of contrast-enhanced mammography (CEM) to supplement standard mammography for breast cancer screening. This method utilizes iodinated contrast medium to enhance the visualization of breast lesions by assessing tumor neovascularization. CEM will be offered to women with dense breast tissue who are currently awaiting supplemental ultrasound screening. It is designed to be performed in conjunction with regular mammography, offering a more efficient and cost-effective alternative to MRI, with comparable sensitivity in detecting breast cancer. Participants will undergo the CEM procedure in a single visit, allowing for reduced wait times and improved detection rates compared to traditional methods. The procedure is well-tolerated, with minimal side effects, and provides a quicker and more accessible option for supplemental breast cancer screening.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• Women presenting at Rose Ages Breast Health Center, who are currently waiting for supplemental screening Ultrasound, according to pre-established guidelines at TOH for supplemental screening.
• Women ages 50-69 years of age
• Those willing to participate in the study, sign an informed consent and undergo IV iodinated contrast injection
• Women with dense breasts (category C or D) and normal mammograms (BI-RADS 1 or 2)
• No evidence of renal disease

Exclusion Criteria

• Patients with renal insufficiency (reduced eGFR <20ml/min)
• Previous allergic reactions to Iodine-based contrast.
• Prior contrast allergy (CT contrast)
• Thyroid Disease

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 69 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma

INDUSTRY

Sponsor Role: collaborator

Jean Seely

OTHER

Sponsor Role: lead

Responsible Party

Jean Seely

Physician Medical Imaging

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Dr. Jean Seely Principal Investigator,, MD FRCPC

Role: PRINCIPAL_INVESTIGATOR

Ottawa Hospital Research Institute

Locations

The Ottawa Hospital

Ottawa, Ontario, Canada

Countries

Canada

Central Contacts

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

Role: CONTACT

jeseely@toh.ca

613-737-8899 ext. Ext. 73665

Dr. Betty Anne Schwarz, Director of Research Services, DProf, RN BA MSc

Role: CONTACT

baschwarz@ohri.ca

613-798-5555 ext. Ext. 17522

Facility Contacts

Dr. Jean Seely Principal Investigator, MD FRCPC

Role: primary

jeseely@toh.on.ca

Other Identifiers

OHSN- REB 20240828-01H

Identifier Type: -

Identifier Source: org_study_id