Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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 in 4-6 hours after the routine iopromide 370 mgI/ml-enhanced ductography for the clinical diagnosis of patients with suspected pathologic nipple discharge.
The main questions aim to answer are:
After enrollment, subjects underwent CESM again within 4-6 hours post completing previous routine ductography to obtain a late-phase ductal image, which contains a low-energy image and a subtracted image obtained from the post processing.
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 explore the optimization of the ductography technique and attempt to make a systematic description of the mammary duct structure in the Chinese population of patients with pathological nipple discharge, and thus to assess the clinical value of this delayed imaging protocol, including the effectiveness of the diagnostic dimension of the disease and the safety of the radiation dose and the degree of patient tolerance.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Contrast-enhanced spectral mammography arm | Experimental | Subjects receiving contrast-enhanced spectral mammography (CESM) 4-6 hours after the routine iopromide 370 mgI/ml-enhanced ductography |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| contrast-enhanced spectral mammography | Diagnostic Test | After enrollment, subjects should undergo contrast-enhanced spectral mammography again within 4-6 hours post completing previous routine ductography to obtain a late-phase ductal image, which contains a low-energy image and a subtracted image obtained from the post processing |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of changes from baseline in imaging diagnosis caused by the results of delayed ductal imaging | Changes include any of the following:
| 4-6 hours after the routine iopromide 370 mgI/ml-enhanced ductography |
| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic accuracy of delayed ductal imaging results for the nature of the lesion | Accuracy = (Number of true positive + Number of true negative) /total number x 100% with using pathological findings as reference standard | 4-6 hours after the routine iopromide 370 mgI/ml-enhanced ductography |
| Percentage of changes from baseline in imaging diagnosis caused by the results of delayed ductal imaging in patients with dense breasts. |
| Measure | Description | Time Frame |
|---|---|---|
| The rate of reported examination-related adverse events occurred within 7 days of delayed ductal imaging. | Any discomfort and associated medical diagnoses post ductal imagine | 7 days post delayed ductal imaging. |
| The average gland dose of delayed ductal imaging. |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fan Yang, Dr. | Contact | 008685726114 | fyang@vip.163.com | |
| Juan Tao, Dr. | Contact | 008685726114 | taojuan@hust.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Fan Yang, Dr. | Union Hospital of Tongji Medical College of Huazhong University of Science and Technology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Union Hospital of Tongji Medical College of Huazhong University of Science and Technology | Recruiting | Wuhan | Hubei | 430000 | China |
China Policy does not allow investigator to disclose individual participant data.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
Changes include any of the following:
|
| 4-6 hours after the routine iopromide 370 mgI/ml-enhanced ductography |
| Percentage of changes from baseline in imaging diagnosis caused by the results of delayed ductal imaging in patients with non-palpable breast mass/no abnormal findings on palpation | Changes include any of the following:
| 4-6 hours after the routine iopromide 370 mgI/ml-enhanced ductography |
| Kappa values for the evaluation of diagnostic imaging results of delayed ductal imaging by different radiologists. | Evaluate the agreement on the diagnostic evaluation of delayed images by assessors using the Kappa test. | 4-6 hours after the routine iopromide 370 mgI/ml-enhanced ductography |
| Scores for diagnostic confidence of radiologists before and after obtaining delayed ductal imaging result. | on a 5-point rating scale (1-5) | 4-6 hours after the routine iopromide 370 mgI/ml-enhanced ductography |
Total radiation of low-energy and subtracted images of delayed ductal imaging from the craniocaudal projection (CC) and the mediolateral projection (ML) of either mammary gland |
| During imaging procedure |
| ID | Term |
|---|---|
| D005687 | Galactorrhea |
| ID | Term |
|---|---|
| D007775 | Lactation Disorders |
| D011644 | Puerperal Disorders |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided