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| Name | Class |
|---|---|
| Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| **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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Lesion Characterization | 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. | Up to one year. |
| Patient Experience |
| Measure | Description | Time Frame |
|---|---|---|
| Procedure Safety | Monitor and report any adverse events, including allergic reactions to the contrast medium and other side effects during and after the procedure. | Three years from the study start date. |
| Cost-Effectiveness |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jean Seely Department of Radiology, Radiation Oncology, MD, FRCPC, MD, FRCPC | Contact | 613-737-8899 | Ext. 73665 | jeseely@toh.ca |
| Dr. Betty Anne Schwarz, Director of Research Services, DProf, RN BA MSc | Contact | 613-798-5555 | Ext. 17522 | baschwarz@ohri.ca |
| Name | Affiliation | Role |
|---|---|---|
| Dr. Jean Seely Principal Investigator,, MD FRCPC | Ottawa Hospital Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Ottawa Hospital | Ottawa | Ontario | K1H 9L6 | Canada |
Only aggregate data will be shared.
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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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.
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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.
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A patient-reported survey measuring comfort, satisfaction, and perceived usefulness of CEM compared to traditional mammography. |
| Immediate post-procedure. |
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.
| Three years from study start. |
| D017437 |
| Skin and Connective Tissue Diseases |