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NCT Number: NCT06993246

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

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.

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Key information

Conditions

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

Age range

50 year–69 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

The Ottawa Hospital

Ottawa, Ontario, K1H 9L6, Canada

Location contact

Dr. Jean Seely Principal Investigator, MD FRCPC

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Detection Rate of Breast Cancer

    Time frame: Three years from the study start date.

    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.

Secondary outcomes

  1. Lesion Characterization

    Time frame: Up to one year.

    Assessment of the ability of CEM to accurately characterize breast lesions in terms of malignancy (benign or malignant). This will be evaluated by comparing CEM findings with biopsy results.

  2. Patient Experience

    Time frame: Immediate post-procedure.

    A patient-reported survey measuring comfort, satisfaction, and perceived usefulness of CEM compared to traditional mammography.

Other outcomes

  1. Procedure Safety

    Time frame: Three years from the study start date.

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

  2. Cost-Effectiveness

    Time frame: Three years from study start.

    Evaluation of the cost-effectiveness of CEM compared to conventional breast cancer screening methods, taking into account the costs of imaging, diagnosis, and follow-up procedures.

Study contacts

Contact information is provided by the study sponsor or research team.

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

CONTACT

[email protected]

613-798-5555 ext. Ext. 17522

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

CONTACT

[email protected]

613-737-8899 ext. Ext. 73665

Sponsors and collaborators

Lead sponsor

Jean Seely

Other

Collaborators

  • Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma

Registry information

Official study title

Does Supplemental Contrast-enhanced Mammography Have a Benefit in Women With a Personal History of Breast Cancer and Dense Breast Tissue? A Prospective Cohort Study.

Acronym: CEM

Important dates

Study start
2025
Primary completion
2026
Study completion
2028
First posted
May 28, 2025
Registry last updated
May 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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