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NCT Number: NCT07608081

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

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.

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Key information

Conditions

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

Age range

18 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

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

Diagnostic Test

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.

Primary outcomes

  1. efficacy evaluation

    Time frame: From enrollment to the end of surgery

    For 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.

  2. Differentiation between benign and malignant lesions

    Time frame: From enrollment to the end of surgery

    With puncture biopsy or surgical pathology serving as the gold standard, MRI parameters are used to distinguish benign from malignant lesions

Study contacts

Contact information is provided by the study sponsor or research team.

Caiyang Li

CONTACT

[email protected]

+8613658700171

Zhenhui Z Li

CONTACT

[email protected]

+8613698736132

Sponsors and collaborators

Lead sponsor

Yunnan Cancer Hospital

Other

Registry information

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
May 27, 2026
Registry last updated
May 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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