Contrast Enhanced Spectral Mammography for the Evaluation of Pathologic Nipple Discharge (NCT05056844) | Clinical Trial Compass
RecruitingNot Applicable
Contrast Enhanced Spectral Mammography for the Evaluation of Pathologic Nipple Discharge
United States66 participantsStarted 2021-04-15
Plain-language 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.
Who can participate
Age range
25 Years – 85 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Sensitivity of contrast enhancement of contrast enhanced spectral mammography (CESM)
Timeframe: through study completion, an average of 1 year