Quantitative Assessment of Diffusion Spectrum Imaging in Breast Cancer

NCT05159323 | Unknown

• 1 other identifier: SYSEC-KY-KS-2021-182
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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).

Conditions

Breast Carcinoma; Magnetic Resonance Imaging; Diffusion Spectrum Imaging

Outcome Measures

Primary Outcomes (1)

• Pathologic characteristic

  Estrogen receptor (ER) status of breast cancer

  Up to 2 months

Secondary Outcomes (1)

• Pathologic characteristic

  Up to 2 months

Other Outcomes (3)

• Pathologic characteristic

  Up to 2 months

• Pathologic characteristic

  Up to 2 months

• Pathologic characteristic

  Up to 2 months

Study Arms (1)

Diffusion Spectrum Imaging

EXPERIMENTAL

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

Interventions

Diffusion Spectrum Imaging DIAGNOSTIC_TEST

A novel diffusion-based magnetic resonance imaging method

Diffusion Spectrum Imaging

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xiang Zhang: lead

Study Sites (1)

Department of Radiology, Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University

Guangzhou, Guangdong, 510120, China

RECRUITING

Related Publications (1)

• Zhang X, Qiu Y, Jiang W, Yang Z, Wang M, Li Q, Liu Y, Yan X, Yang G, Shen J. Mean Apparent Propagator MRI: Quantitative Assessment of Tumor-Stroma Ratio in Invasive Ductal Breast Carcinoma. Radiol Imaging Cancer. 2024 Jul;6(4):e230165. doi: 10.1148/rycan.230165.

  PMID: 38874529 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Xiang Zhang, M.D.

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Li Ling, Ph.D.

CONTACT

+86-20-81336505; sys_iit@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Department of Radiology

Study Record Dates

• First Submitted: November 21, 2021
• First Posted: December 16, 2021
• Study Start: August 20, 2021
• Primary Completion: August 19, 2022
• Study Completion: August 19, 2022
• Last Updated: December 16, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)