Quantitative Assessment of Diffusion Spectrum Imaging in Breast Cancer
- Conditions
- Breast Carcinoma; Magnetic Resonance Imaging; Diffusion Spectrum Imaging
- Interventions
- Diagnostic Test: Diffusion Spectrum Imaging
- Registration Number
- NCT05159323
- Lead Sponsor
- Xiang Zhang
- Brief Summary
This project intends to prospectively collect patients with suspected breast malignant tumors by ultrasound or mammography. After routine MRI scanning, all patients underwent diffusion spectrum imaging (DSI) sequence scanning. The inclusion criteria were as follows: (1) breast cancer was confirmed by surgery or biopsy. (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. The exclusion criteria were as follows: (1) patients who had received treatment before DSI scanning; (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.
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
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 64
- Breast cancer was confirmed by surgery or biopsy.
- 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.
- Routine MRI and DSI scans were performed within one week before the pathologic examination.
- Patients who had received treatment before DSI scanning.
- Patients who underwent breast tumor biopsy within two weeks before DSI image acquisition.
- Pathology results of breast masses were other diseases besides breast cancer.
- Post-processing of DSI data cannot be performed due to poor image quality, such as motion artifacts.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Diffusion Spectrum Imaging 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.
- Primary Outcome Measures
Name Time Method Pathologic characteristic Up to 2 months Estrogen receptor (ER) status of breast cancer
- Secondary Outcome Measures
Name Time Method Pathologic characteristic Up to 2 months Progesterone receptor (PR) status of breast cancer
Trial Locations
- Locations (1)
Department of Radiology, Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
🇨🇳Guangzhou, Guangdong, China