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Contrast Enhanced Spectral Mammography for Pathologic Nipple Discharge

This study is looking at a special type of mammogram called Contrast Enhanced Spectral Mammography (CESM) to evaluate pathologic nipple discharge (PND). CESM is like a regular mammogram but uses an iodine-based contrast agent injected into your vein to make tissues and blood vessels clearer. Researchers want to see if CESM is better than standard mammography at finding the cause of nipple discharge and detecting breast cancer, potentially reducing the need for unnecessary biopsies. You may be able to join if you are a woman between 25 and 85 years old, have PND, and can receive the contrast agent. The main goal is to see how well CESM detects the problem causing the discharge. The study plans to enroll 66 participants, but its current status is unclear.

Study design
This is an interventional study, meaning participants will receive specific procedures. It aims to enroll 66 women.
What's involved
You would undergo CESM, Digital Tomosynthesis Mammography (DBT), receive an iodinated contrast agent, and complete questionnaires. The study completion is an average of 1 year.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint is measured through study completion, an average of 1 year.

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NCT05056844

Contrast Enhanced Spectral Mammography for the Evaluation of Pathologic Nipple Discharge

Active, Not Recruiting
NAAges 25–85InterventionalDiagnostic
M.D. Anderson Cancer Center
~40 participants
Updated 2026-08-11 on ClinicalTrials.gov
What's tested:Contrast Enhanced Digital MammographyDigital Tomosynthesis MammographyIodinated Contrast AgentQuestionnaire Administration

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Sensitivity of contrast enhancement of contrast enhanced spectral mammography (CESM)
Measured over through study completion, an average of 1 year

Conditions

Breast Carcinoma

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Breast Carcinoma

Where it's being run

1 sites across 1 states
Texas1

Study leadership

  • Olena Weaver, MD · PRINCIPAL_INVESTIGATOR · M.D. Anderson Cancer Center

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Sensitivity of contrast enhancement of contrast enhanced spectral mammography (CESM)through study completion, an average of 1 year

    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).