Breast Cancer
Conditions
Keywords
Mammography screening, Contrast-Enhanced Mammography, Dense breasts
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.
Interventions
DIAGNOSTIC_TESTContrast-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.
Sponsors
Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma
Jean Seely
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Masking description
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.
Intervention model description
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.
Eligibility
Sex/Gender
FEMALE
Age
50 Years to 69 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Detection Rate of Breast Cancer | 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
| Measure | Time frame | Description |
|---|---|---|
| Lesion Characterization | 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. |
| Patient Experience | Immediate post-procedure. | A patient-reported survey measuring comfort, satisfaction, and perceived usefulness of CEM compared to traditional mammography. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Procedure Safety | 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. |
| Cost-Effectiveness | 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. |
Countries
Canada
Contacts
Primary ContactDr. Jean Seely Department of Radiology, Radiation Oncology, MD, FRCPC, MD, FRCPC
Backup ContactDr. Betty Anne Schwarz, Director of Research Services, DProf, RN BA MSc
Outcome results
None listed