Quantitative Assessment of Diffusion Spectrum Imaging in Breast Cancer
Primary Purpose
Breast Carcinoma; Magnetic Resonance Imaging; Diffusion Spectrum Imaging
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Diffusion Spectrum Imaging
Sponsored by
About this trial
This is an interventional diagnostic trial for Breast Carcinoma; Magnetic Resonance Imaging; Diffusion Spectrum Imaging
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.
Sites / Locations
- Department of Radiology, Sun Yat-Sen Memorial Hospital, Sun Yat-Sen UniversityRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Diffusion Spectrum Imaging
Arm Description
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.
Outcomes
Primary Outcome Measures
Pathologic characteristic
Estrogen receptor (ER) status of breast cancer
Secondary Outcome Measures
Pathologic characteristic
Progesterone receptor (PR) status of breast cancer
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05159323
Brief Title
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
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Recruiting
Study Start Date
August 20, 2021 (Actual)
Primary Completion Date
August 19, 2022 (Anticipated)
Study Completion Date
August 19, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Xiang Zhang
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Carcinoma; Magnetic Resonance Imaging; Diffusion Spectrum Imaging
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
64 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Diffusion Spectrum Imaging
Arm Type
Experimental
Arm Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Diffusion Spectrum Imaging
Intervention Description
A novel diffusion-based magnetic resonance imaging method
Primary Outcome Measure Information:
Title
Pathologic characteristic
Description
Estrogen receptor (ER) status of breast cancer
Time Frame
Up to 2 months
Secondary Outcome Measure Information:
Title
Pathologic characteristic
Description
Progesterone receptor (PR) status of breast cancer
Time Frame
Up to 2 months
Other Pre-specified Outcome Measures:
Title
Pathologic characteristic
Description
Human epidermal growth factor 2 (HER-2) status of breast cancer
Time Frame
Up to 2 months
Title
Pathologic characteristic
Description
Ki-67 status of breast cancer
Time Frame
Up to 2 months
Title
Pathologic characteristic
Description
Lymphatic vessel invasion (LVI) status of breast cancer
Time Frame
Up to 2 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Li Ling, Ph.D.
Phone
+86-20-81336505
Email
sys_iit@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiang Zhang, M.D.
Organizational Affiliation
Sun Yat-sen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Radiology, Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510120
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jun Shen, M.D.
Phone
+86-20-81338253
Email
shenjun@mail.sysu.edu.cn
12. IPD Sharing Statement
Plan to Share IPD
No
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Quantitative Assessment of Diffusion Spectrum Imaging in Breast Cancer
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