Nipple DischargeNCT06033573
Preoperative Assessment of Pathological Nipple Discharge With Delayed Ductal Imaging of Contrast-enhanced Mammography
A study testing contrast-enhanced spectral mammography in people with Nipple Discharge, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Nipple Discharge
- What is being tested?
- contrast-enhanced spectral mammography
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2023to 1 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Union Hospital of Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, 430000
Juan Tao, Dr., 008685726114, taojuan@hust.edu.cn
About this study
Official title: Preoperative Assessment of Pathological Nipple Discharge With Delayed Ductal Imaging of Contrast-enhanced Spectral Mammography: an Exploratory Study
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:
Read more
- Percentage of changes from baseline in imaging diagnosis caused by the results of delayed imaging.
- The rate of reported examination-related adverse events occurred within 7 days of the delayed ductal imaging.
- 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.
Read the 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
- Being tested
- contrast-enhanced spectral mammography
- Keywords
- pathologic nipple discharge, contrast-enhanced spectral mammography
- Medical subject headings
- Galactorrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
contrast-enhanced spectral mammographyDiagnostic 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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Diagnostic Test: contrast-enhanced spectral mammography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of changes from baseline in imaging diagnosis caused by the results of delayed ductal imaging
Changes include any of the following:
- Changes in disease classification (based on The International Statistical Classification of Diseases, ICD-10)
- Any changes in the number, location and\or size (maximum and minimum diameters) of all lesions found
- Changes in the severity/nature of the disease with reference to the Breast Imaging Reporting and Data System classification standard
Measured: 4-6 hours after the routine iopromide 370 mgI/ml-enhanced ductography
Secondary outcomes (5)
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
Measured: 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.
Changes include any of the following:
- Changes in disease classification (based on The International Statistical Classification of Diseases, ICD-10)
- Any changes in the number, location and\or size (maximum and minimum diameters) of all lesions found
- Changes in the severity/nature of the disease with reference to the Breast Imaging Reporting and Data System classification standard
Measured: 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:
- Changes in disease classification (based on The International Statistical Classification of Diseases, ICD-10)
- Any changes in the number, location and\or size (maximum and minimum diameters) of all lesions found
- Changes in the severity/nature of the disease with reference to the Breast Imaging Reporting and Data System classification standard
Measured: 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.
Measured: 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)
Measured: 4-6 hours after the routine iopromide 370 mgI/ml-enhanced ductography
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2023
- Study start1 Aug 2023
- Primary completion1 Aug 2024 (estimated)
- Study completion1 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nipple DischargeStudies of the same condition, open and under way.
- More trials run by Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fan Yang, Dr., Principal investigator, Union Hospital of Tongji Medical College of Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06033573
- Sponsor's protocol ID
- 0519-01
- Status last verified
- Aug 2023
- First submitted
- 5 Sep 2023
- Last updated
- 13 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: China Policy does not allow investigator to disclose individual participant data.
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Assessment of Pathological Nipple Discharge With Delayed Ductal Imaging of Contrast-enhanced Spectral Mammography: an Exploratory Study
- ClinicalTrials.gov ID
- NCT06033573
- Acronym / sponsor ID
- 0519-01
- Conditions
- Nipple Discharge
- Keywords
- pathologic nipple discharge, contrast-enhanced spectral mammography
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 1 Aug 2024 (estimated)
- Study completion
- 1 Aug 2024 (estimated)
- First posted
- 13 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Percentage of changes from baseline in imaging diagnosis caused by the results of delayed imaging.
- The rate of reported examination-related adverse events occurred within 7 days of the delayed ductal imaging.
- 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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Contrast-enhanced spectral mammography arm | Experimental | Diagnostic Test: contrast-enhanced spectral mammographySubjects receiving contrast-enhanced spectral mammography (CESM) 4-6 hours after the routine iopromide 370 mgI/ml-enhanced ductography |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| contrast-enhanced spectral mammographyAfter 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 | Diagnostic test | Contrast-enhanced spectral mammography arm |
Primary outcome
Percentage of changes from baseline in imaging diagnosis caused by the results of delayed ductal imaging
Time frame: 4-6 hours after the routine iopromide 370 mgI/ml-enhanced ductography
Changes include any of the following: 1. Changes in disease classification (based on The International Statistical Classification of Diseases, ICD-10) 2. Any changes in the number, location and\or size (maximum and minimum diameters) of all lesions found 3. Changes in the severity/nature of the disease with reference to the Breast Imaging Reporting and Data System classification standard
5 secondary outcomes
Diagnostic accuracy of delayed ductal imaging results for the nature of the lesion
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 4-6 hours after the routine iopromide 370 mgI/ml-enhanced ductography
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2023.
- Individual participant dataSharing planned: No. China Policy does not allow investigator to disclose individual participant data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fan Yang, Dr. principal investigator
Union Hospital of Tongji Medical College of Huazhong University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing contrast-enhanced spectral mammography in people with Nipple Discharge, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fan Yang, Dr. (008685726114, fyang@vip.163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of changes from baseline in imaging diagnosis caused by the results of delayed ductal imaging (time frame: 4-6 hours after the routine iopromide 370 mgI/ml-enhanced ductography). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2023.