Status:
UNKNOWN
Preoperative Assessment of Pathological Nipple Discharge With Delayed Ductal Imaging of Contrast-enhanced Mammography
Lead Sponsor:
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Conditions:
Nipple Discharge
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
The goal of the prospective, interventional, self-control, open, single-center clinical study: is to evaluate the value of the delayed ductal imaging of contrast enhanced Spectral Mammography acquired...
Detailed Description
As an exploratory study, the study plans to conduct another imaging using contrast-enhanced spectral mammography (CESM) 4-6 hours after the routine iopromide 370 mgI/ml-enhanced ductography, so as to ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2024
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06033573
Start Date
August 1 2023
End Date
August 1 2024
Last Update
September 13 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Union Hospital of Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, China, 430000