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Study on the Correlation Between the Quantitative Parameters of Mr Mean Cell Size Imaging and the Histopathological Characteristics of Breast Cancer

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05373628
Acronym
OGSE
Enrollment
200
Registered
2022-05-13
Start date
2022-05-11
Completion date
2023-07-01
Last updated
2022-05-13

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;OGSE

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).

Interventions

DIAGNOSTIC_TESTGradient and pulse imaging

A novel diffusion-based magnetic resonance imaging method

Sponsors

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

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

1. Breast cancer was confirmed by operation 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 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.

Design outcomes

Primary

MeasureTime frameDescription
Pathologic characteristicUp to 2 monthsEstrogen receptor (ER) status of breast cancer
2. 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 5, 2026