MammographyNCT06713915
Diagnostic Performance of Contrast-Enhanced Mammography
An observational study of Mammography, run by ZHOU Yidong at 1 site in China.
Trial summary
Contrast-Enhanced Mammography (CEM) is a functional breast imaging technology. Like magnetic resonance imaging (MRI), CEM neovascularization enhancement can improve cancer detection rates, while lack of enhancement may lead to benign determination. Read more about this study
- Who is it for?
- Ages 30 to 80 years, women only
- Conditions the study is for
- Mammography
- What is being tested?
- Contrast-Enhanced Mammography
- How many people
- 600 participants
- Where
- 1 siteChina
- Study dates
- Jan 2025to Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 30 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients with breast lesions BI-RADS 4 and above treated at the Breast Surgery Department of Peking Union Medical College Hospital.
Who may be able to join
- Breast ultrasound or/and general mammography suggest that the lesion is BI-RADS 4 or above;
- Willing to undergo enhanced mammography examination;
- Agree to perform tumor core needle biopsy or excisional biopsy to confirm pathological diagnosis when necessary.
Who cannot join
- Allergy to iodinated contrast;
- Pregnant and lactating women;
- Suffering from kidney disease or abnormal kidney function, or undergoing renal dialysis;
- The breast is too large to be completely included in the full-field mammography examination at one time; ○5 Those with breast implants.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Department of Breast Surgery,Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
Yidong Zhou, Master, +86-10-69158720, zhouyd@pumch.cn
Yanna Zhang, Doctor, +86-10-69158703, pumchzyn@sohu.com
About this study
Official title: Diagnostic Performance of Contrast-Enhanced Mammography in Suspicious Breast Lesions
Contrast-Enhanced Mammography (CEM) is a functional breast imaging technology. Like magnetic resonance imaging (MRI), CEM neovascularization enhancement can improve cancer detection rates, while lack of enhancement may lead to benign determination. The advantages of CEM are dramatically apparent in women with dense breasts. The purpose of this study was to investigate the additional diagnostic value of CEM added to the standard practice of mammography plus ultrasonography(US) in patients with suspicious breast lesions.
This study was a single-center prospective-retrospective combined observational study. In the prospective part, women with suspected breast abnormalities undergo prospective CEM evaluation, including acquisition of low energy (LE) images and recombined images (RI) showing enhancement, concurrently with breast US. The retrospective part selected the mammography and breast US data of female patients with suspected breast abnormalities who had previous baseline matching.
- Conditions
- Mammography
- Being tested
- Contrast-Enhanced Mammography
- Keywords
- breast cancer, breast ultrasound, contrast enhanced mammography
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Contrast-Enhanced MammographyDiagnostic test
Only patients in the prospective cohort will undergo CEM in addition to breast ultrasound.
| Study group | Role | What they receive |
|---|---|---|
| prospective cohort | Women with suspected breast abnormalities in prospective cohort will be prospectively evaluated with CEM, including acquisition of low-energy (LE) images and reconstructed images (RI) showing enhancement, concurrently with breast ultrasound (US) evaluation. Receives: Diagnostic Test: Contrast-Enhanced Mammography | |
| retrospective cohort | The retrospective cohort will select the mammography and breast US data (BI-RADS score) of female patients with suspected breast abnormalities who had previous baseline matching. |
What is being measured
The primary outcome is the main question the study is designed to answer.
lesion biopsy rate
Total biopsy rate (including core needle biopsy and lesion excision biopsy) in patients with BI-RADS 4 and above with and without CEM.
Measured: 2 years
breast cancer detection rate
Proportion of breast cancer detected among all patients undergoing biopsy.
Measured: 2 years
Secondary outcomes (1)
number of BI-RADS score upgrade
number of BI-RADS score upgrade during follow-up
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2024
- Study startJan 2025 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MammographyStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ZHOU Yidong
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, ZHOU Yidong, Peking Union Medical College Hospital
- Investigators
- Yanna Zhang, M.D, Study chair, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06713915
- Sponsor's protocol ID
- PUMCH-breast-CEM
- Status last verified
- Nov 2024
- First submitted
- 27 Nov 2024
- Last updated
- 3 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Performance of Contrast-Enhanced Mammography in Suspicious Breast Lesions
- ClinicalTrials.gov ID
- NCT06713915
- Acronym / sponsor ID
- PUMCH-breast-CEM
- Conditions
- Mammography
- Keywords
- breast cancer, breast ultrasound, contrast enhanced mammography
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- ZHOU YidongUniversity, hospital or other
- Study start
- Jan 2025 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 3 Dec 2024 (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.
Contrast-Enhanced Mammography (CEM) is a functional breast imaging technology. Like magnetic resonance imaging (MRI), CEM neovascularization enhancement can improve cancer detection rates, while lack of enhancement may lead to benign determination. The advantages of CEM are dramatically apparent in women with dense breasts. The purpose of this study was to investigate the additional diagnostic value of CEM added to the standard practice of mammography plus ultrasonography(US) in patients with suspicious breast lesions.
This study was a single-center prospective-retrospective combined observational study. In the prospective part, women with suspected breast abnormalities undergo prospective CEM evaluation, including acquisition of low energy (LE) images and recombined images (RI) showing enhancement, concurrently with breast US. The retrospective part selected the mammography and breast US data of female patients with suspected breast abnormalities who had previous baseline matching.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| prospective cohort | – | Diagnostic Test: Contrast-Enhanced MammographyWomen with suspected breast abnormalities in prospective cohort will be prospectively evaluated with CEM, including acquisition of low-energy (LE) images and reconstructed images (RI) showing enhancement, concurrently with breast ultrasound (US) evaluation. |
| retrospective cohort | – | –The retrospective cohort will select the mammography and breast US data (BI-RADS score) of female patients with suspected breast abnormalities who had previous baseline matching. |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with breast lesions BI-RADS 4 and above treated at the Breast Surgery Department of Peking Union Medical College Hospital.
Key inclusion criteria (3 listed)
- Breast ultrasound or/and general mammography suggest that the lesion is BI-RADS 4 or above;
- Willing to undergo enhanced mammography examination;
- Agree to perform tumor core needle biopsy or excisional biopsy to confirm pathological diagnosis when necessary.
Key exclusion criteria (4 listed)
- Allergy to iodinated contrast;
- Pregnant and lactating women;
- Suffering from kidney disease or abnormal kidney function, or undergoing renal dialysis;
- The breast is too large to be completely included in the full-field mammography examination at one time; ○5 Those with breast implants.
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 MammographyOnly patients in the prospective cohort will undergo CEM in addition to breast ultrasound. | Diagnostic test | prospective cohort |
Primary outcome
lesion biopsy rate
Time frame: 2 years
Total biopsy rate (including core needle biopsy and lesion excision biopsy) in patients with BI-RADS 4 and above with and without CEM.
breast cancer detection rate
Time frame: 2 years
Proportion of breast cancer detected among all patients undergoing biopsy.
1 secondary outcome
number of BI-RADS score upgrade
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2024.
- Individual participant dataSharing planned: No
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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.
Yanna Zhang, M.D study chair
Peking Union Medical College Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mammography, run by ZHOU Yidong 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 3 inclusion and 4 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: opening soon, as of the sponsor's last update on 3 Dec 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yidong Zhou, Master (+86-10-69158720, zhouyd@pumch.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
lesion biopsy rate (time frame: 2 years). The study lists 2 primary outcomes in all. 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 3 Dec 2024.