Dynamic Contrast-enhanced MRI Combined With IVIM-DWI for Early Prediction of Chemosensitivity in Liver MBC

NCT05550090 | Unknown

• 1 other identifier: ZCHBC022
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to further use DCE-MRI and ivim-dwi to predict the chemotherapy sensitivity of liver metastasis of breast cancer at an early stage, and to predict the treatment response of tumor at an early stage by using the changes of their functional parameters, and to compare the efficacy and advantages of IVIM functional parameters and DCE-MRI parameters in predicting the efficacy.To explore the efficacy of "perfusion" and "diffusion" parameters of magnetic resonance imaging as "biomarkers" for early prediction of chemotherapy response and prognosis of breast cancer patients with liver metastasis. And to provide guidance for optimizing the clinical treatment scheme of breast cancer patients with liver metastasis. At the same time, this study will use the method of artificial intelligence to deeply mine the images, and further find out the indicators for early prediction of the therapeutic effect of liver metastasis of breast cancer.

Conditions

Metastatic Breast Cancer in the Liver

Keywords

Liver metastasis; Breast cancer; Efficacy prediction

Outcome Measures

Primary Outcomes (2)

• Correlation between DCE-MRI parameters combined with IVIM parameters and short-term efficacy of chemotherapy in patients with liver metastasis of breast cancer

  Correlation between DCE-MRI parameters (Ktrans, Ve, Kep) combined with IVIM parameters (D\*, D, f) and short-term efficacy of chemotherapy in patients with liver metastasis of breast cancer

  September 2025

• Correlation between DCE-MRI parameters combined with IVIM parameters and long-term efficacy of chemotherapy in patients with liver metastasis of breast cancer

  Correlation between DCE-MRI parameters (Ktrans, Ve, Kep) combined with IVIM parameters (D\*, D, f) and long-term efficacy of chemotherapy in patients with liver metastasis of breast cancer

  September 2025

Secondary Outcomes (2)

• The consistency of DCE-MRI parameters and IVIM parameters between different observers and the same observer.

  September 2025

• Using artificial intelligence method to deeply mine images, find out new indicators to predict the curative effect of liver metastasis treatment of breast cancer in early stage.

  September 2025

Study Arms (1)

Patients with liver metastasis from breast cancer requiring antitumor therapy

Patients with liver metastasis from breast cancer requiring antitumor therapy

Drug: Chemotherapy

Interventions

Chemotherapy DRUG

All patients were given 2 cycles of chemotherapy, including the chemotherapy recommended by the clinical treatment guidelines for advanced metastatic breast cancer, which can be combined with targeted or immune or endocrine therapy.

Also known as: Chemotherapy can be combined with targeted or immunotherapy or endocrine therapy.

Patients with liver metastasis from breast cancer requiring antitumor therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with liver metastasis from breast cancer requiring at least 2 cycles of systemic chemotherapy

You may qualify if:

• The primary lesion was pathologically confirmed to be breast cancer, and the patients diagnosed by two imaging methods or pathologically confirmed to be liver metastasis of breast cancer had at least one liver metastasis with the longest diameter ≥ 10mm;
• No second primary malignant tumor;
• ECOG score, 0-2 ;
• The organ function is normal and can tolerate chemotherapy and other anti-tumor treatments;
• The patient plans to receive systemic chemotherapy or systemic anti-tumor treatment, and the whole process of cooperative treatment. The patient has good compliance with the planned treatment and follow-up, can understand the research process of this study and sign a written informed consent；
• Contraception during the study period and within 6 months after treatment, non lactation period.

You may not qualify if:

• For patients contraindicated to MR examination, such as built-in metal instruments and allergy to contrast agents;
• The patient had diffuse liver metastasis or the number of liver metastatic tumors was more than 5;
• Patients who cannot complete 2 cycles of chemotherapy or systemic anti-tumor treatment;
• Unable to cooperate with follow-up；
• Patients who are not suitable for the study according to the investigator.

Sponsors & Collaborators

• Zhejiang Cancer Hospital: lead

Study Sites (1)

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310022, China

RECRUITING

Related Publications (18)

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MeSH Terms

Conditions

Breast Neoplasms

Interventions

Drug Therapy; Immunotherapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Therapeutics; Immunomodulation; Biological Therapy

Study Officials

• Ping Huang

  Zhejiang Cancer Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ping Huang

CONTACT

+8613685766632; zlyyhp@163.com

Xiaojia Wang

CONTACT

+8613906500190; wxiaojia0803@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: September 18, 2022
• First Posted: September 22, 2022
• Study Start: September 16, 2022
• Primary Completion: September 16, 2025
• Study Completion: December 30, 2025
• Last Updated: September 27, 2022

Record last verified: 2022-09

Locations

CN (1)