Breast Carcinoma Clinical Trial
Official title:
Contrast Enhanced Spectral Mammography (CESM) for the Evaluation of Pathologic Nipple Discharge: A Pilot Study
This clinical trial studies contrast enhanced spectral mammography (CESM) for the evaluation of pathologic nipple discharge. CESM is similar to standard mammography, but it includes an intravenous (by vein) injection of an iodine-based contrast, which makes tissue and blood vessels more visible in scans. The goal of this trial is to learn if CESM, is better than standard mammography in quickly and efficiently determining the cause of nipple discharge and detecting breast cancer, if present. CESM may increase the chance of finding breast cancers and lower the risk of having unnecessary biopsies.
Status | Recruiting |
Enrollment | 66 |
Est. completion date | April 30, 2024 |
Est. primary completion date | April 30, 2024 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 25 Years to 85 Years |
Eligibility | Inclusion Criteria: - Women presenting to MDACC for the evaluation of PND as the main or accompanying symptom - Age 25-85 years - Willing to participate in the study and 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 in the absence of a prior history of uneventful administration of iodine-based IV contrast. - Renal insufficiency - Pregnancy or lactation within 6 months - Breast surgery affecting the symptomatic breast within prior 6 months, if it was located within 5 cm from the nipple - Breast biopsy of the symptomatic breast within the last 2 months, if it was located within 5 cm from the nipple - Breast MRI performed within 24 months before the patient presented with qualifying symptoms (MRI performed contemporarily with CEM for the evaluation of new symptoms is not an exclusion criterion). - Known breast cancer or active inflammatory process (such as abscess or mastitis) in the breast of concern |
Country | Name | City | State |
---|---|---|---|
United States | M D Anderson Cancer Center | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
M.D. Anderson Cancer Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Sensitivity of contrast enhancement of contrast enhanced spectral mammography (CESM) | Will be compared to low exposure (LE) images of CESM (full field digital mammogram equivalent) in detecting the causative lesion (invasive malignancy, ductal carcinoma in situ (DCIS), atypia, or papilloma) in patients with pathologic nipple discharge (PND). | through study completion, an average of 1 year |
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