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

NCT06993246 | Not Yet Recruiting

• 1 other identifier: OHSN- REB 20240828-01H
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

Mammography screening; Contrast-Enhanced Mammography; Dense breasts

Outcome Measures

Primary Outcomes (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.

  Three years from the study start date.

Secondary Outcomes (2)

• Lesion Characterization

  Up to one year.

• Patient Experience

  Immediate post-procedure.

Other Outcomes (2)

• Procedure Safety

  Three years from the study start date.

• Cost-Effectiveness

  Three years from study start.

Study Arms (1)

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

EXPERIMENTAL

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.

Diagnostic Test: Contrast-Enhanced Mammography (CEM)

Interventions

Contrast-Enhanced Mammography (CEM) 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.

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

Eligibility Criteria

• Age: 50 Years - 69 Years
• Gender Eligibility Details: * 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
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Jean Seely: lead
• Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma: collaborator

Study Sites (1)

The Ottawa Hospital

Ottawa, Ontario, K1H 9L6, Canada

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Dr. Jean Seely Principal Investigator,, MD FRCPC

  Ottawa Hospital Research Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

CONTACT

613-737-8899; jeseely@toh.ca

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

CONTACT

613-798-5555; baschwarz@ohri.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: There are no additional parties masked in this clinical trial. The study is open-label, meaning that participants, care providers, investigators, and outcomes assessors are all aware of the intervention being performed (Contrast-Enhanced Mammography). No masking of roles is applied in this study.
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Physician Medical Imaging

Model Details: The study follows a \*\*prospective cohort design\*\*, where eligible participants are recruited and followed over time to evaluate the outcomes of Contrast-Enhanced Mammography (CEM) in comparison to traditional screening methods like ultrasound and MRI. Participants are women aged 50-69 years with dense breast tissue and a personal history of breast cancer. They will undergo CEM as part of their routine screening process. The study aims to assess key outcomes, including cancer detection rates, biopsy results, patient acceptance, and screening wait times. Data will be collected on screening outcomes, including abnormal interpretation rates, positive predictive values, and follow-up results over two years. The study also compares the performance of CEM with historical data from previous screening modalities.

Study Record Dates

• First Submitted: May 14, 2025
• First Posted: May 28, 2025
• Study Start: September 15, 2025
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2028
• Last Updated: May 28, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)