Breast Carcinoma Clinical Trial
Official title:
Contrast-Enhanced Mammography (CEM) for the Evaluation and Targeted Biopsy of Suspicious Mammographic Architectural Distortions
Verified date | January 2024 |
Source | M.D. Anderson Cancer Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This clinical trial examines a new imaging technology, contrast-enhanced mammography, in predicting breast cancer. Contrast-enhanced mammography is similar to standard mammography, but it includes an intravenous (by vein) injection of iodine-based contrast, which makes tissue and blood vessels more visible in scans. Contrast-enhanced mammography may work better in detecting cancer in the breast that is not seen on other imaging tests and may help doctors find the most suspicious areas of the breast to biopsy, which could increase the chances of finding breast cancer.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | March 1, 2026 |
Est. primary completion date | March 1, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 25 Years to 85 Years |
Eligibility | Inclusion Criteria: - Women with suspicious MADs recommended for a stereotactic biopsy who underwent their diagnostic imaging work-up resulting in a biopsy recommendation at MD Anderson Cancer Center (MDACC) or at an outside facility with a technically acceptable quality of diagnostic mammography, and who are planning to have their biopsy at MDACC - Age 25-85 years - Willing to participate in the study, undergo an IV placement, able to undergo iodinated contrast injection, and able to provide informed consent Exclusion Criteria: - Reported history of an allergic reaction to iodinated contrast - History of anaphylactic reaction to any substance - Renal insufficiency - Pregnancy or lactation within 6 months - Breast surgery affecting the site of interest within prior 6 months - Breast biopsy at the site of interest within the last 2 months |
Country | Name | City | State |
---|---|---|---|
United States | M D Anderson Cancer Center | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
M.D. Anderson Cancer Center | National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Accuracy of contrast-enhanced mammography (CEM) | Will examine the accuracy of CEM compared to full field digital mammography (FFDM) in predicting invasive malignancy or ductal carcinoma in situ (DCIS) in patients with mammographic architectural distortion (MAD)s. | Up to 3 years | |
Secondary | Sensitivity of CEM, FFDM, digital breast tomosynthesis (DBT), and ultrasound (US) in predicting invasive malignancy or DCIS | Will compare the sensitivity of CEM with that of FFDM, DBT, and US in predicting invasive malignancy or DCIS by using McNemar's test. | Up to 3 years | |
Secondary | Specificity of CEM, FFDM, digital breast tomosynthesis (DBT), and US in predicting invasive malignancy or DCIS | Will compare the specificity of CEM with that of FFDM, DBT, and US in predicting invasive malignancy or DCIS by using McNemar's test | Up to 3 years | |
Secondary | Negative predictive value of CEM, FFDM, digital breast tomosynthesis (DBT), and US in predicting invasive malignancy or DCIS | Up to 3 years | ||
Secondary | Positive predictive value of CEM, FFDM, digital breast tomosynthesis (DBT), and US in predicting invasive malignancy or DCIS | Up to 3 years | ||
Secondary | Degree of enhancement on CEM | Will examine the degree of enhancement on CEM and its correlation with the visibility of MAD on FFDM and DBT, or DBT only, and with the probability of malignancy. | Up to 3 years | |
Secondary | Proportion of cases in which CEM changes the original target for a stereotactic biopsy | We will estimate the proportion of cases in which CEM changes the original target along with an exact 95% confidence interval. | Up to 3 years | |
Secondary | Cancer detection rate | Will examine cancer detection rate and the outcomes (need for additional imaging, biopsies, and final pathologic results) of incidental CEM findings. | Up to 3 years |
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