Clinical trial NCT05159323: Quantitative Assessment of Diffusion Spectrum Imaging in Breast Cancer
Official title: Quantitative Parameters of Diffusion Spectrum Imaging: Correlation With Histopathologic Characteristics in Patients With Breast Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Carcinoma; Magnetic Resonance Imaging; Diffusion Spectrum Imaging
Lead sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2021-12-16
Enrollment: 64
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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).


Eligibility criteria: Inclusion Criteria:

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.

Exclusion Criteria:

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.

Primary outcomes:
measure: Pathologic characteristic
timeFrame: Up to 2 months
Secondary outcomes:
measure: Pathologic characteristic
timeFrame: Up to 2 months
Other outcomes:
measure: Pathologic characteristic
timeFrame: Up to 2 months
measure: Pathologic characteristic
timeFrame: Up to 2 months
measure: Pathologic characteristic
timeFrame: Up to 2 months
Locations:
city: Guangzhou
country: China
facility: Department of Radiology, Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
state: Guangdong
Study officials:
affiliation: Sun Yat-sen University
name: Xiang Zhang, M.D.
role: PRINCIPAL_INVESTIGATOR
References: