Clinical trial · Interventional
Study on the Correlation Between the Quantitative Parameters of Mr Mean Cell Size Imaging and the Histopathological Characteristics of Breast Cancer
Quantitative Parameters of Cell Size Imaging: Correlation With Histopathological Features in Patients With Breast Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Patients with breast masses and suspected breast malignancies by ultrasound / mammography were prospectively included. After routine MRI scanning, all patients underwent average cell size imaging sequence scanning, and finally underwent breast MRI enhanced scanning. Inclusion criteria of breast cancer patients: (1) breast cancer confirmed by surgery or biopsy; (2) The status of estrogen receptor (ER), progesterone receptor (PR), human epidermal growth factor-2 (HER-2), Ki-67 and lymphatic vessel invasion (LVI) in breast cancer were clearly diagnosed by pathology; (3) Routine MRI, PGSE and OGSE scans were performed within 1 week before pathological examination. Exclusion criteria: (1) breast tumor patients who had received treatment before PGSE and OGSE sequence scanning; (2) Patients who underwent breast tumor puncture within 2 weeks before PGSE and OGSE sequence scanning; (3) Patients with breast masses without surgery or biopsy after PGSE and OGSE sequence scanning; (4) The breast mass was confirmed to be other diseases except breast cancer by pathological examination; (5) Due to poor image quality caused by motion artifacts or other reasons, PGSE and OGSE sequence post-processing cannot be carried out. All subjects were required to sign written informed consent. Breast MRI data were collected using Philips ingenia DNA 3T MR scanner in the Netherlands. All subjects used standardized breast MRI scanning schemes, including T2 weighted imaging (T2WI), T1 weighted imaging (T1WI), diffusion weighted imaging (DWI), PGSE, OGSE and contrast dynamic enhancement (DCE). Three quantitative parameters of VIN, DEX and D were derived from MATLAB software. The correlation between the quantitative parameters of mean cell size imaging and pathological indexes Er, PR, HER-2, Ki-67 and LVI was evaluated by Spearman correlation analysis. The predictive factors of the quantitative parameters of mean cell size model for different pathological characteristics of breast cancer were determined by logistic regression model, The diagnostic efficacy of quantitative parameters of mean cell size model for pathological classification indexes was evaluated by subject operating characteristic (ROC) curve and area under curve (AUC).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Carcinoma; Magnetic Resonance Imaging;OGSE | Breast Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Gradient and pulse imaging | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Gradient and pulse imaging
- description
- All subjects used standardized breast MRI scanning schemes, including T2 weighted imaging (T2WI), T1 weighted imaging (T1WI), diffusion weighted imaging (DWI), PGSE, OGSE and contrast dynamic enhancement (DCE). Three quantitative parameters of VIN, DEX and D are derived on MATLAB software
- interventionNames
- Diagnostic Test: Gradient and pulse imaging
Primary outcomes (2)
- measure
- Pathologic characteristic
- timeFrame
- Up to 2 months
- description
- Estrogen receptor (ER) status of breast cancer
- measure
- 2. Pathologic characteristic
- timeFrame
- Up to 2 months
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: 1. Breast cancer was confirmed by operation or biopsy; 2. The status of estrogen receptor (ER), progesterone receptor (PR), human epidermal growth factor-2 (HER-2), Ki-67 and lymphatic vessel invasion (LVI) in breast cancer were clearly diagnosed by pathology; 3. Routine MRI and mean cell size imaging sequence scanning were performed within 1 week before pathological examination Exclusion Criteria: (1) Breast cancer patients who had received treatment before mean cell size imaging sequence scanning; (2) Patients who had undergone breast tumor puncture within 2 weeks before the mean cell size imaging sequence scan; (3) Patients with breast masses without surgery or biopsy after mean cell size imaging sequence scanning; (4) The breast mass was confirmed to be other diseases except breast cancer by pathological examination; (5) The image quality is poor due to motion artifacts or other reasons, so the average cell size imaging post-processing cannot be carried out.
References
Publications (1)
- DERIVEDSu Y, Qiu Y, Huang X, Peng Y, Yang Z, Ding M, Hu L, Wang Y, Zhao C, Qian W, Zhang X, Shen J. Benign and Malignant Breast Lesions: Differentiation Using Microstructural Metrics Derived from Time-Dependent Diffusion MRI. Radiol Imaging Cancer. 2025 May;7(3):e240287. doi: 10.1148/rycan.240287. PMID 40214515