Quantitative Assessment of Diffusion Spectrum Imaging in Breast Cancer

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

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).

Study Overview

• Status: Recruiting
• Conditions: Breast Carcinoma; Magnetic Resonance Imaging; Diffusion Spectrum Imaging
• Intervention / Treatment: Diagnostic test: Diffusion Spectrum Imaging

• Study Type: Interventional
• Enrollment (Anticipated): 64
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Li Ling, Ph.D.; Phone Number: +86-20-81336505; Email: sys_iit@163.com

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510120
      • Recruiting
      • Department of Radiology, Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
      • Contact: Jun Shen, M.D.; Phone Number: +86-20-81338253; Email: shenjun@mail.sysu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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.	Diagnostic test: Diffusion Spectrum Imaging; A novel diffusion-based magnetic resonance imaging method

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pathologic characteristic	Human epidermal growth factor 2 (HER-2) status of breast cancer	Up to 2 months
Pathologic characteristic	Ki-67 status of breast cancer	Up to 2 months
Pathologic characteristic	Lymphatic vessel invasion (LVI) status of breast cancer	Up to 2 months

Collaborators and Investigators

• Sponsor: Xiang Zhang
• Investigators: Principal Investigator: Xiang Zhang, M.D., Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 20, 2021
• Primary Completion (ANTICIPATED): August 19, 2022
• Study Completion (ANTICIPATED): August 19, 2022

Study Registration Dates

• First Submitted: November 21, 2021
• First Submitted That Met QC Criteria: December 2, 2021
• First Posted (ACTUAL): December 16, 2021

Study Record Updates

• Last Update Posted (ACTUAL): December 16, 2021
• Last Update Submitted That Met QC Criteria: December 2, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: SYSEC-KY-KS-2021-182

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No