Breast Cancer Clinical Trial
— TOCEMOfficial title:
Improving Surveillance of Women With Personal History of Breast Cancer Using Contrast-Enhanced Mammography (CEM)
Verified date | January 2024 |
Source | University of Pittsburgh |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This is a prospective clinical trial that will examine if contrast-enhanced mammography substantially improves breast cancer detection compared to mammography with tomosynthesis, with minimal increase in false-positives, in women with a personal history of breast cancer.
Status | Active, not recruiting |
Enrollment | 1647 |
Est. completion date | June 30, 2027 |
Est. primary completion date | December 1, 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 30 Years to 85 Years |
Eligibility | Inclusion Criteria: -Asymptomatic women, ages 30-85, with a personal history of breast cancer who have had at least one routine mammogram since treatment. Exclusion Criteria: - Women with a history of prior iodinated contrast reaction - Women with implant(s) in the breasts to be screened (as this creates artifacts and diagnostic performance of imaging in women with implants likely does not generalize to those without implants, and the sample size with implants would be too small to infer conclusions) - Women who have had bilateral mastectomy - Women with a history of kidney failure or estimated glomerular filtration rate (eGFR) < 45 mL/min - Pregnancy or lactation - Women actively being treated for cancer of any type with chemotherapy - Lump or other breast symptoms - Abnormality on prior breast imaging that is being followed. |
Country | Name | City | State |
---|---|---|---|
United States | Magee Womancare Passavant Cranberry | Cranberry Township | Pennsylvania |
United States | Magee Womancare Monroeville | Monroeville | Pennsylvania |
United States | Magee Womens Hospital | Pittsburgh | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Wendie Berg | Breast Cancer Research Foundation |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Cancer Detection | Number of participants with cancer detected with contrast-enhanced mammography compared to tomosynthesis. Number of patients recalled for additional testing by each imaging test who do not have cancer (false positives). Outcomes will be assessed for both prevalence and incidence screens. | 48 months | |
Secondary | Reader Validation | Reader validation will be performed at study conclusion: number of cancers detected with contrast-enhanced mammography or tomosynthesis. | 48 months |
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