Skip to main content
Clinical Trials/NCT05373628
NCT05373628
Unknown
Not Applicable

Quantitative Parameters of Cell Size Imaging: Correlation With Histopathological Features in Patients With Breast Cancer

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University1 site in 1 country200 target enrollmentMay 11, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Breast Carcinoma; Magnetic Resonance Imaging;OGSE
Sponsor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Enrollment
200
Locations
1
Primary Endpoint
Pathologic characteristic
Last Updated
3 years ago

Overview

Brief Summary

Patients with breast masses and suspected breast malignancies by ultrasound / mammography were prospectively included. After routine MRI scanning, all patients underwent average cell size imaging sequence scanning, and finally underwent breast MRI enhanced scanning. Inclusion criteria of breast cancer patients: (1) breast cancer confirmed by surgery or biopsy; (2) The status of estrogen receptor (ER), progesterone receptor (PR), human epidermal growth factor-2 (HER-2), Ki-67 and lymphatic vessel invasion (LVI) in breast cancer were clearly diagnosed by pathology; (3) Routine MRI, PGSE and OGSE scans were performed within 1 week before pathological examination. Exclusion criteria: (1) breast tumor patients who had received treatment before PGSE and OGSE sequence scanning; (2) Patients who underwent breast tumor puncture within 2 weeks before PGSE and OGSE sequence scanning; (3) Patients with breast masses without surgery or biopsy after PGSE and OGSE sequence scanning; (4) The breast mass was confirmed to be other diseases except breast cancer by pathological examination; (5) Due to poor image quality caused by motion artifacts or other reasons, PGSE and OGSE sequence post-processing cannot be carried out. All subjects were required to sign written informed consent.

Breast MRI data were collected using Philips ingenia DNA 3T MR scanner in the Netherlands. All subjects used standardized breast MRI scanning schemes, including T2 weighted imaging (T2WI), T1 weighted imaging (T1WI), diffusion weighted imaging (DWI), PGSE, OGSE and contrast dynamic enhancement (DCE). Three quantitative parameters of VIN, DEX and D were derived from MATLAB software. The correlation between the quantitative parameters of mean cell size imaging and pathological indexes Er, PR, HER-2, Ki-67 and LVI was evaluated by Spearman correlation analysis. The predictive factors of the quantitative parameters of mean cell size model for different pathological characteristics of breast cancer were determined by logistic regression model, The diagnostic efficacy of quantitative parameters of mean cell size model for pathological classification indexes was evaluated by subject operating characteristic (ROC) curve and area under curve (AUC).

Registry
clinicaltrials.gov
Start Date
May 11, 2022
End Date
July 1, 2023
Last Updated
3 years ago
Study Type
Interventional
Study Design
Single Group
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Xiang Zhang

Department of Radiology

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Eligibility Criteria

Inclusion Criteria

  • Breast cancer was confirmed by operation or biopsy;
  • The status of estrogen receptor (ER), progesterone receptor (PR), human epidermal growth factor-2 (HER-2), Ki-67 and lymphatic vessel invasion (LVI) in breast cancer were clearly diagnosed by pathology;
  • Routine MRI and mean cell size imaging sequence scanning were performed within 1 week before pathological examination

Exclusion Criteria

  • (1) Breast cancer patients who had received treatment before mean cell size imaging sequence scanning; (2) Patients who had undergone breast tumor puncture within 2 weeks before the mean cell size imaging sequence scan; (3) Patients with breast masses without surgery or biopsy after mean cell size imaging sequence scanning; (4) The breast mass was confirmed to be other diseases except breast cancer by pathological examination; (5) The image quality is poor due to motion artifacts or other reasons, so the average cell size imaging post-processing cannot be carried out.

Outcomes

Primary Outcomes

Pathologic characteristic

Time Frame: Up to 2 months

Estrogen receptor (ER) status of breast cancer

2. Pathologic characteristic

Time Frame: Up to 2 months

Progesterone receptor (PR) status of breast cancer

Study Sites (1)

Loading locations...

Similar Trials