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

Last updated: September 11, 2023
Sponsor: Wuhan Union Hospital, China
Overall Status: Active - Recruiting

Phase

N/A

Condition

Female Hormonal Deficiencies/abnormalities

Treatment

contrast-enhanced spectral mammography

Clinical Study ID

NCT06033573
0519-01
  • Ages 18-65
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

Exclusion Criteria:

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

Study Design

Total Participants: 60
Treatment Group(s): 1
Primary Treatment: contrast-enhanced spectral mammography
Phase:
Study Start date:
August 01, 2023
Estimated Completion Date:
August 01, 2024

Study 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.

Connect with a study center

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

    Wuhan, Hubei 430000
    China

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.