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The Value of Time-Dependent Diffusion MRI and Magnetic Resonance Elastography in the Precise Diagnosis and Efficacy Assessment of Breast Cancer

The Value of Time-Dependent Diffusion MRI and Magnetic Resonance Elastography in the Precise Diagnosis and Efficacy Assessment of Breast Cancer

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07608081
Enrollment
1000
Registered
2026-05-27
Start date
2025-10-01
Completion date
2027-10-01
Last updated
2026-05-27

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

Conditions

Breast Cancer

Brief summary

We consecutively enrolled patients presenting with breast space-occupying lesions at our hospital. Medical imaging data from simultaneously acquired ultrafast DCE-MRI, time-dependent diffusion MRI (TDD-MRI), magnetic resonance elastography (MRE), andvirtual magnetic resonance elastography(vMRE), along with clinical and pathological data, were collected. The study aims to evaluate and explore the clinical application value of these multimodal imaging techniques in the precision diagnosis, treatment, and prognosis of breast cancer. The findings are intended to provide a robust imaging basis for formulating and adjusting more precise, individualized treatment plans and prognostic assessments for patients. Ultimately, this research seeks to improve patient quality of life, optimize the allocation of medical resources, and advance the development of precision medicine.

Interventions

DIAGNOSTIC_TESTThe Value of Time-Dependent Diffusion MRI and Magnetic Resonance Elastography in the Precise Diagnosis and Efficacy Assessment of Breast Cancer

The MRI scan is part of the standard treatment protocol. Medical imaging data from simultaneously acquired ultrafast DCE-MRI, time-dependent diffusion MRI (TDD-MRI), magnetic resonance elastography (MRE), andvirtual magnetic resonance elastography(vMRE), along with clinical and pathological data, were collected.

Sponsors

Yunnan Cancer Hospital
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. Age ≥ 18 years old 2. Female patients with BI-RADS class 4 or above breast lesions detected by mammography or ultrasound 3. Perform breast new technology MRI examination (ultra fast DCE-MRI、OGSE 、MRE、vMRE)within one week before biopsy or surgery

Exclusion criteria

1. Previously received breast radiotherapy, chemotherapy, surgery, or targeted therapy 2. Unable to cooperate in completing MRI examination 3. The image data contains serious artifacts (such as motion artifacts and metal artifacts), making it impossible to measure parameters 4. The lesion cannot be clearly identified and outlined on the image 5. Pregnant and lactating women 6. Combined with severe liver, liver, and kidney diseases, coagulation dysfunction, or other malignant tumors

Design outcomes

Primary

MeasureTime frameDescription
efficacy evaluationFrom enrollment to the end of surgeryFor patients requiring neoadjuvant therapy, after completing the corresponding cycles of neoadjuvant treatment, the patient's surgical pathology results are used as the gold standard to assess tumor regression and determine whether pathological complete response (pCR) has been achieved.
Differentiation between benign and malignant lesionsFrom enrollment to the end of surgeryWith puncture biopsy or surgical pathology serving as the gold standard, MRI parameters are used to distinguish benign from malignant lesions

Countries

China

Contacts

CONTACTCaiyang Li
2020429049@kmmu.edu.cn+8613658700171
CONTACTZhenhui Z Li
lizhenhui@kmmu.edu.cn+8613698736132

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 28, 2026