Preoperative Assessment of Pathological Nipple Discharge With Delayed Ductal Imaging of Contrast-enhanced Mammography

NCT ID: NCT06033573

Last Updated: 2023-09-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-01
• Study Completion Date: 2024-08-01

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.

Conditions

Nipple Discharge

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Contrast-enhanced spectral mammography arm

Subjects receiving contrast-enhanced spectral mammography (CESM) 4-6 hours after the routine iopromide 370 mgI/ml-enhanced ductography

Group Type: EXPERIMENTAL

contrast-enhanced spectral mammography

Intervention Type: 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

Interventions

contrast-enhanced spectral mammography

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

Intervention Type: DIAGNOSTIC_TEST

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Fan Yang, Dr.

Role: PRINCIPAL_INVESTIGATOR

Union Hospital of Tongji Medical College of Huazhong University of Science and Technology

Locations

Union Hospital of Tongji Medical College of Huazhong University of Science and Technology

Wuhan, Hubei, China

Site Status: RECRUITING

Countries

China

Central Contacts

Fan Yang, Dr.

Role: CONTACT

fyang@vip.163.com

008685726114

Juan Tao, Dr.

Role: CONTACT

taojuan@hust.edu.cn

008685726114

Facility Contacts

Juan Tao, Dr.

Role: primary

taojuan@hust.edu.cn

008685726114

Other Identifiers

0519-01

Identifier Type: -

Identifier Source: org_study_id