Breast DiseasesNCT06497023
Radiomics Model Based on DCE-MRI and Ultrasound Images for Breast Lesion Classification
An observational study of Breast Diseases, run by Ma Zhe at 1 site in China.
Trial summary
To develop and compare multi-modality radiomics models based on DCE-MRI, B-mode ultrasound (BMUS) and strain elastography (SE) images for classifying benign and malignant breast lesions. Read more about this study
- Who is it for?
- Ages 15 to 80 years, women only
- Conditions the study is for
- Breast Diseases
- How many people
- 550 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2018to 30 Mar 2024
- Phase
- Observational
- 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 15 to 80 years
- Women only
- Child, Adult, Older adult
Study population: Patients with breast lesions attending the First Affiliated Hospital of Shandong First Medical University were selected
Who may be able to join
- Patients with breast lesions underwent biopsy or surgical resection between January 1, 2018 and March 30, 2024.
Who cannot join
- pathologicalresult of biopsy or surgical specimen was unavailable for the target lesion;
- patients without DCE-MRI, BMUS and SE examinations before biopsy or surgery within one month;
- patients hadperformed radiotherapy, chemotherapy, or breast biopsy before MRI and ultrasound examinations;
- patients without completeDICOM data for each examination;
- patients with poor-qualityimages.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multi-modality Radiomics Diagnostic Model Based on DCE-MRI and Ultrasound Images for Benign and Malignant Breast Lesion Classification
To develop and compare multi-modality radiomics models based on DCE-MRI, B-mode ultrasound (BMUS) and strain elastography (SE) images for classifying benign and malignant breast lesions.
Read the detailed description
In this retrospective study,555 breast lesions from 555 patients who underwent DCE-MRI, BMUS and SE examinations were randomly divided into training (n =388) and testing (n = 167) datasets. Radiomics features were extracted from manually contoured images. The inter-class correlation coefficient (ICC), Mann-Whitney U test and the least absolute shrinkage and selection operator (LASSO) regression was applied for feature selection and radiomics signature building.Nine radiomics models including four single-modality radiomics models (DCE-3D, DCE-2D, BMUS, and SE), four multi-modality radiomics models (BMUS + SE, DCE-3D + BMUS, DCE-3D + SE, and DCE-3D+SE+BMUS), and the combination diagnostic model(clinical features and DCE-3D+SE+BMUS features) were developed and evaluated by their discrimination, calibration, and clinical usefulness.
- Conditions
- Breast Diseases
- Medical subject headings
- Breast Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| maligant | female patients with maligant breast masses who underwent biopsy and/or surgical resection. | |
| benign | female patients with benign breast masses who underwent biopsy and/or surgical resection. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of different diagnostic models
The accuracy of nine diagnostic models, including four single-modality radiomics models (DCE-3D, DCE-2D, BMUS, and SE), four multi-modality radiomics models (BMUS + SE, DCE-3D + BMUS, DCE-3D + SE, and DCE-3D+SE+BMUS),and the combination diagnostic model is the ratio of the sum of True Positive and True Negative to the total of True Positive, True Negative, False Positive, and False Negative.
Measured: Immediately evaluated after the radiomcis diagnostic model was built
Secondary outcomes (1)
Sensitivity of different diagnostic models
The sensitivity of nine diagnostic models, four single-modality radiomics models (DCE-3D, DCE-2D, BMUS, and SE), including four multi-modality radiomics models (BMUS + SE, DCE-3D + BMUS, DCE-3D + SE, and DCE-3D+SE+BMUS), and the combination diagnostic model is the ratio of True Positive to the sum of True Positive and False Negative.
Measured: Immediately evaluated after the radiomcis diagnostic model was built
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2024
- Study start1 Jan 2018
- Primary completion30 Mar 2024
- Study completion30 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast DiseasesStudies 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
- Retrospective
- Enrolment
- 550 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ma Zhe
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ma Zhe, Qianfoshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06497023
- Sponsor's protocol ID
- YXLL-KY-2024(055)
- Status last verified
- Jul 2024
- First submitted
- 23 Jun 2024
- Last updated
- 11 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Lack of resources or infrastructure: Sharing IPDs requires resources and infrastructure to ensure data security, manage access requests and provide necessary documentation. Currently these resources are not well developed, so it may be difficult to share IPDs.
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-modality Radiomics Diagnostic Model Based on DCE-MRI and Ultrasound Images for Benign and Malignant Breast Lesion Classification
- ClinicalTrials.gov ID
- NCT06497023
- Acronym / sponsor ID
- YXLL-KY-2024(055)
- Conditions
- Breast Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 550 participants (actual)
- Lead sponsor
- Ma ZheUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 30 Mar 2024 (actual)
- Study completion
- 30 Mar 2024 (actual)
- First posted
- 11 Jul 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.
To develop and compare multi-modality radiomics models based on DCE-MRI, B-mode ultrasound (BMUS) and strain elastography (SE) images for classifying benign and malignant breast lesions.
Detailed description
In this retrospective study,555 breast lesions from 555 patients who underwent DCE-MRI, BMUS and SE examinations were randomly divided into training (n =388) and testing (n = 167) datasets. Radiomics features were extracted from manually contoured images. The inter-class correlation coefficient (ICC), Mann-Whitney U test and the least absolute shrinkage and selection operator (LASSO) regression was applied for feature selection and radiomics signature building.Nine radiomics models including four single-modality radiomics models (DCE-3D, DCE-2D, BMUS, and SE), four multi-modality radiomics models (BMUS + SE, DCE-3D + BMUS, DCE-3D + SE, and DCE-3D+SE+BMUS), and the combination diagnostic model(clinical features and DCE-3D+SE+BMUS features) were developed and evaluated by their discrimination, calibration, and clinical usefulness.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| maligant | – | –female patients with maligant breast masses who underwent biopsy and/or surgical resection. |
| benign | – | –female patients with benign breast masses who underwent biopsy and/or surgical resection. |
Who may qualify
- Ages
- 15 to 80 years
- Sex
- Female only
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with breast lesions attending the First Affiliated Hospital of Shandong First Medical University were selected
Key inclusion criteria (1 listed)
- Patients with breast lesions underwent biopsy or surgical resection between January 1, 2018 and March 30, 2024.
Key exclusion criteria (5 listed)
- pathologicalresult of biopsy or surgical specimen was unavailable for the target lesion;
- patients without DCE-MRI, BMUS and SE examinations before biopsy or surgery within one month;
- patients hadperformed radiotherapy, chemotherapy, or breast biopsy before MRI and ultrasound examinations;
- patients without completeDICOM data for each examination;
- patients with poor-qualityimages.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Accuracy of different diagnostic models
Time frame: Immediately evaluated after the radiomcis diagnostic model was built
The accuracy of nine diagnostic models, including four single-modality radiomics models (DCE-3D, DCE-2D, BMUS, and SE), four multi-modality radiomics models (BMUS + SE, DCE-3D + BMUS, DCE-3D + SE, and DCE-3D+SE+BMUS),and the combination diagnostic model is the ratio of the sum of True Positive and True Negative to the total of True Positive, True Negative, False Positive, and False Negative.
1 secondary outcome
Sensitivity of different diagnostic models
Time frame: Immediately evaluated after the radiomcis diagnostic model was built
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2024.
- Individual participant dataSharing planned: No. Lack of resources or infrastructure: Sharing IPDs requires resources and infrastructure to ensure data security, manage access requests and provide necessary documentation. Currently these resources are not well developed, so it may be difficult to share IPDs.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Breast Diseases, run by Ma Zhe 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 1 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: finished, as of the sponsor's last update on 11 Jul 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of different diagnostic models (time frame: Immediately evaluated after the radiomcis diagnostic model was built). 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 11 Jul 2024.