Contrast Enhanced Spectral Mammography (CESM) for the Evaluation of Pathologic Nipple Discharge: A Pilot Study
M.D. Anderson Cancer Center
Summary
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.
Description
PRIMARY OBJECTIVE: I. To evaluate the added sensitivity of contrast enhancement of CESM (represented by the subtracted contrast images of CESM) compared to low energy \[LE\] images of CESM (full field digital mammogram \[FFDM\] equivalent) in detecting the causative lesion (invasive malignancy, ductal carcinoma in situ \[DCIS\], atypia, or papilloma) in patients with pathologic nipple discharge (PND). SECONDARY OBJECTIVES: I. To compare the sensitivity, specificity, negative predictive value, and positive predictive value of CESM versus DBT and ultrasound (US) in predicting invasive maligna…
Eligibility
- Age range
- 25–85 years
- Sex
- Female
- Healthy volunteers
- No
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…
Interventions
- ProcedureContrast Enhanced Digital Mammography
Undergo CESM
- ProcedureDigital Tomosynthesis Mammography
Undergo DBT
- DrugIodinated Contrast Agent
Given iodine-based contrast agent IV
- OtherQuestionnaire Administration
Ancillary studies
Location
- M D Anderson Cancer CenterHouston, Texas