Clinical trial · Interventional
Contrast Enhanced Spectral Mammography for the Evaluation of Pathologic Nipple Discharge
Contrast Enhanced Spectral Mammography (CESM) for the Evaluation of Pathologic Nipple Discharge: A Pilot Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Carcinoma | Breast Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Contrast Enhanced Digital Mammography | Procedure | — | UNRESOLVED |
| Digital Tomosynthesis Mammography | Procedure | — | UNRESOLVED |
| Iodinated Contrast Agent | Drug | — | UNRESOLVED |
| Questionnaire Administration | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Diagnostic (CESM, DBT)
- description
- Patients receive iodine-based contrast agent IV then undergo CESM over 10-15 minutes. Patients who have not undergone standard of care DBT within 3 months from the study, also undergo DBT.
- interventionNames
- Procedure: Contrast Enhanced Digital Mammography
- Procedure: Digital Tomosynthesis Mammography
- Drug: Iodinated Contrast Agent
- Other: Questionnaire Administration
Primary outcomes (1)
- measure
- Sensitivity of contrast enhancement of contrast enhanced spectral mammography (CESM)
- timeFrame
- through study completion, an average of 1 year
- description
- 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).
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 25 Years
- Maximum age
- 85 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available