NCT07608081

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for not_applicable breast-cancer

Timeline
15mo left

Started Oct 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress35%
Oct 2025Oct 2027

Study Start

First participant enrolled

October 1, 2025

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

April 27, 2026

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 27, 2026

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2027

Last Updated

May 27, 2026

Status Verified

May 1, 2026

Enrollment Period

2 years

First QC Date

April 27, 2026

Last Update Submit

May 19, 2026

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (2)

  • efficacy evaluation

    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.

    From enrollment to the end of surgery

  • Differentiation between benign and malignant lesions

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

    From enrollment to the end of surgery

Study Arms (1)

The Value of Time-Dependent Diffusion MRI and Magnetic Resonance Elastography in the Precise Diagnos

EXPERIMENTAL

Consecutively enrolled patients presenting with breast 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.

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

Interventions

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

The Value of Time-Dependent Diffusion MRI and Magnetic Resonance Elastography in the Precise Diagnos

Eligibility Criteria

Age18 Years - 80 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yunnan Cancer Hospital

Kunming, Yunnan, 650118, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Elasticity Imaging Techniques

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

UltrasonographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Central Study Contacts

Caiyang Li

CONTACT

+86136587001712020429049@kmmu.edu.cn

Zhenhui Z Li

CONTACT

+8613698736132lizhenhui@kmmu.edu.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 27, 2026

First Posted

May 27, 2026

Study Start

October 1, 2025

Primary Completion (Estimated)

October 1, 2027

Study Completion (Estimated)

October 1, 2027

Last Updated

May 27, 2026

Record last verified: 2026-05

Locations

CN(1)