Quantitative Assessment of Diffusion Spectrum Imaging in Breast Cancer

Study Overview
=================
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).

Official Title
-----------------
Quantitative Parameters of Diffusion Spectrum Imaging: Correlation With Histopathologic Characteristics in Patients With Breast Cancer

Conditions
-----------------
Breast Carcinoma; Magnetic Resonance Imaging; Diffusion Spectrum Imaging

Intervention / Treatment
-----------------
* Diagnostic Test: Diffusion Spectrum Imaging


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Diffusion Spectrum Imaging<br>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. | Diagnostic Test: Diffusion Spectrum Imaging<br>* A novel diffusion-based magnetic resonance imaging method<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pathologic characteristic | Estrogen receptor (ER) status of breast cancer | Up to 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pathologic characteristic | Progesterone receptor (PR) status of breast cancer | Up to 2 months |