Clinical trial NCT06033573: Preoperative Assessment of Pathological Nipple Discharge With Delayed Ductal Imaging of Contrast-enhanced Mammography
Official title: Preoperative Assessment of Pathological Nipple Discharge With Delayed Ductal Imaging of Contrast-enhanced Spectral Mammography: an Exploratory Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Nipple Discharge
Keywords: pathologic nipple discharge
contrast-enhanced spectral mammography
Lead sponsor: Wuhan Union Hospital, China
Sponsor class: OTHER
First posted: 2023-09-13
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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 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:

1. Percentage of changes from baseline in imaging diagnosis caused by the results of delayed imaging.
2. The rate of reported examination-related adverse events occurred within 7 days of the delayed ductal imaging.
3. The average gland dose (AGD) of delayed ductal imaging.

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.

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 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.

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

Primary outcomes:
measure: Percentage of changes from baseline in imaging diagnosis caused by the results of delayed ductal imaging
timeFrame: 4-6 hours after the routine iopromide 370 mgI/ml-enhanced ductography
Secondary outcomes:
measure: Diagnostic accuracy of delayed ductal imaging results for the nature of the lesion
timeFrame: 4-6 hours after the routine iopromide 370 mgI/ml-enhanced ductography
measure: Percentage of changes from baseline in imaging diagnosis caused by the results of delayed ductal imaging in patients with dense breasts.
timeFrame: 4-6 hours after the routine iopromide 370 mgI/ml-enhanced ductography
measure: 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
timeFrame: 4-6 hours after the routine iopromide 370 mgI/ml-enhanced ductography
measure: Kappa values for the evaluation of diagnostic imaging results of delayed ductal imaging by different radiologists.
timeFrame: 4-6 hours after the routine iopromide 370 mgI/ml-enhanced ductography
measure: Scores for diagnostic confidence of radiologists before and after obtaining delayed ductal imaging result.
timeFrame: 4-6 hours after the routine iopromide 370 mgI/ml-enhanced ductography
Other outcomes:
measure: The rate of reported examination-related adverse events occurred within 7 days of delayed ductal imaging.
timeFrame: 7 days post delayed ductal imaging.
measure: The average gland dose of delayed ductal imaging.
timeFrame: During imaging procedure
Locations:
city: Wuhan
country: China
facility: Union Hospital of Tongji Medical College of Huazhong University of Science and Technology
state: Hubei
Study officials:
affiliation: Union Hospital of Tongji Medical College of Huazhong University of Science and Technology
name: Fan Yang, Dr.
role: PRINCIPAL_INVESTIGATOR
References: