Assessing nipple discharge with advanced imaging techniques

Preoperative Assessment of Pathological Nipple Discharge With Delayed Ductal Imaging of Contrast-enhanced Spectral Mammography: an Exploratory Study

This study is testing a new imaging method to see if it can help doctors better diagnose the cause of nipple discharge in patients.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Wuhan Union Hospital, China (other)
• Drugs / interventions: radiation
• Locations: 1 site (Wuhan, Hubei)
• Trial ID: NCT06033573 on ClinicalTrials.gov

What this trial studies

This clinical study evaluates the effectiveness of delayed ductal imaging using contrast-enhanced spectral mammography (CESM) in diagnosing pathological nipple discharge. Participants will undergo CESM 4-6 hours after routine ductography to assess changes in imaging diagnosis, the rate of adverse events, and the average gland dose from the imaging. The study aims to optimize ductography techniques and provide a systematic description of mammary duct structures in the Chinese population. It is a single-center, interventional study focused on improving diagnostic accuracy and patient safety.

Who should consider this trial

Good fit: Ideal candidates are females aged 18-65 who have undergone routine ductography for suspected pathological nipple discharge.

Not a fit: Patients who are pregnant, lactating, or have a history of breast surgery may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance the diagnostic accuracy for patients experiencing pathological nipple discharge.

How similar studies have performed: While this approach is exploratory, similar imaging techniques have shown promise in enhancing diagnostic capabilities in breast imaging.

Eligibility criteria

Inclusion Criteria:

* Females aged 18-65 years old
* Completed routine iopromide 370 mgI/ml enhanced ductography for initial clinical diagnosis of suspected pathological nipple discharge, under the recommendation of the clinician
* Signed informed consent form for this study (signature and date)
* Committed to complying with study procedures and cooperating with the conducting of the full study process
* For women of childbearing age, should have taken contraceptive measures for at least one month prior to screening and must have a negative serum or urine pregnancy test, meanwhile committed to take contraceptive measures during the entire study and continue until a specified time after the end of the study

Exclusion Criteria:

* Pregnant or lactating women
* Experienced any episode of adverse events or discomfort after ductography with iopromide 370 mgI/ml
* Had any history of breast surgery, such as having undergone any invasive examination or surgical treatment due to the studied disease, including but not limited to breast duct micro-endoscopy, puncture biopsy, surgery, etc
* The ductal discharge symptom is more likely caused by other diagnosed/highly suspected diseases rather than a breast lesion, such as pituitary adenomas
* Other conditions are inappropriate for participation in this study judged by the investigator, such as the patient had difficulty to cooperate with ductography procedure, for example, loss of consciousness, communication impairment or nipple anomalies, and overly slender ducts

Where this trial is running

Wuhan, Hubei

• Union Hospital of Tongji Medical College of Huazhong University of Science and Technology — Wuhan, Hubei, China (RECRUITING)

Study contacts

• Principal investigator: Fan Yang, Dr. — Union Hospital of Tongji Medical College of Huazhong University of Science and Technology
• Study coordinator: Fan Yang, Dr.

Conditions: Nipple Discharge, pathologic nipple discharge, contrast-enhanced spectral mammography