Quantitative Assessment of Diffusion Spectrum Imaging in Breast Cancer
NCT ID: NCT05159323
Last Updated: 2021-12-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
64 participants
INTERVENTIONAL
2021-08-20
2022-08-19
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Breast MRI data were collected on a 3T MR scanner (Magnetom skyra, Siemens Healthcare, Erlangen, Germany). All participants used standardized breast MRI scanning schemes, including T2 weighted imaging (T2WI), T1 weighted imaging (T1WI), diffusion-weighted imaging (DWI), DSI, and contrast dynamic enhancement (DCE). A total of 22 GSI quantitative parameters were derived from NeudiLab software that is based on the open-source platform DIPY (diffusion imaging in Python, http://nipy.org/dipy). The correlation between DSI quantitative parameters and pathological indexes (i.e., ER, PR, HER-2, Ki-67, and LVI) was evaluated by Spearman correlation analysis. The independent predictors of GSI quantitative parameters for different pathologic characteristics discrimination in breast cancer were determined by the logistic regression analysis. The predictive performance of DSI quantitative parameters for difference pathologic classifications was assessed by the receiver operating characteristic (ROC) curves and their respective area under the curves (AUCs).
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Diffusion Spectrum Imaging
All participants accept diffusion spectrum imaging, the quantitative parameters of the diffusion spectrum imaging are obtained. The quantitative parameters are compared in different subgroups based on the pathologic examination results.
Diffusion Spectrum Imaging
A novel diffusion-based magnetic resonance imaging method
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Diffusion Spectrum Imaging
A novel diffusion-based magnetic resonance imaging method
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Pathologically diagnosis of estrogen receptor (ER), progesterone receptor (PR), human epidermal growth factor 2 (HER-2), Ki-67, and lymphatic vessel invasion (LVI) status in breast cancer.
3. Routine MRI and DSI scans were performed within one week before the pathologic examination.
Exclusion Criteria
2. Patients who underwent breast tumor biopsy within two weeks before DSI image acquisition.
3. Pathology results of breast masses were other diseases besides breast cancer.
4. Post-processing of DSI data cannot be performed due to poor image quality, such as motion artifacts.
18 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Xiang Zhang
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Xiang Zhang
Department of Radiology
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Xiang Zhang, M.D.
Role: PRINCIPAL_INVESTIGATOR
Sun Yat-sen University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Department of Radiology, Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
Guangzhou, Guangdong, China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Jun Shen, M.D.
Role: primary
References
Explore related publications, articles, or registry entries linked to this study.
Zhang X, Qiu Y, Jiang W, Yang Z, Wang M, Li Q, Liu Y, Yan X, Yang G, Shen J. Mean Apparent Propagator MRI: Quantitative Assessment of Tumor-Stroma Ratio in Invasive Ductal Breast Carcinoma. Radiol Imaging Cancer. 2024 Jul;6(4):e230165. doi: 10.1148/rycan.230165.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
SYSEC-KY-KS-2021-182
Identifier Type: -
Identifier Source: org_study_id