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Quantitative Assessment of Diffusion Spectrum Imaging in Breast Cancer

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05159323
Enrollment
64
Registered
2021-12-16
Start date
2021-08-20
Completion date
2022-08-19
Last updated
2021-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Carcinoma; Magnetic Resonance Imaging; Diffusion Spectrum Imaging

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).

Interventions

DIAGNOSTIC_TESTDiffusion Spectrum Imaging

A novel diffusion-based magnetic resonance imaging method

Sponsors

Xiang Zhang
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Pathologic characteristicUp to 2 monthsEstrogen receptor (ER) status of breast cancer

Secondary

MeasureTime frameDescription
Pathologic characteristicUp to 2 monthsProgesterone receptor (PR) status of breast cancer

Other

MeasureTime frameDescription
Pathologic characteristicUp to 2 monthsHuman epidermal growth factor 2 (HER-2) status of breast cancer

Countries

China

Contacts

Primary ContactLi Ling, Ph.D.
sys_iit@163.com+86-20-81336505

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026