NCT05056844 · M.D. Anderson Cancer Center
Contrast Enhanced Spectral Mammography for the Evaluation of Pathologic Nipple Discharge
What this study is about
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 given through a vein (IV) (by vein) injection of an iodine-based contrast, which makes tissue and blood vessels more visible in scans.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Houston, Texas
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 9, 2025 · Source of record for eligibility and locations