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

September 23, 2022 updated by: Huang Ping, Zhejiang Cancer Hospital

Clinical Study of Dynamic Contrast-enhanced Magnetic Resonance Imaging Combined With IVIM-DWI for Early Prediction of Chemosensitivity in Liver Metastasis of Breast Cance

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The first MR examination was arranged within 7 days before treatment (baseline). The MRI scanning sequence included conventional T1, T2 weighted imaging, T1+dynamic contrast enhanced imaging, and IVIM-DWI imaging.The second and third MR examinations were arranged within 7 days after the first chemotherapy and the second chemotherapy. The examination steps and parameters were the same as those of the first examination.

Study Type

Observational

Enrollment (Anticipated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310022
        • Recruiting
        • Zhejiang Cancer Hospital
        • Contact:
        • Principal Investigator:
          • Ping Huang

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

  1. 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;
  2. No second primary malignant tumor;
  3. ECOG score, 0-2 ;
  4. The organ function is normal and can tolerate chemotherapy and other anti-tumor treatments;
  5. 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；
  6. Contraception during the study period and within 6 months after treatment, non lactation period.

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with liver metastasis from breast cancer requiring antitumor therapy
Drug: Chemotherapy
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.
Other Names:
  • Chemotherapy can be combined with targeted or immunotherapy or endocrine therapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation between DCE-MRI parameters combined with IVIM parameters and short-term efficacy of chemotherapy in patients with liver metastasis of breast cancer
Time Frame: September 2025
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
Time Frame: September 2025
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
The consistency of DCE-MRI parameters and IVIM parameters between different observers and the same observer.
Time Frame: September 2025
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.
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zhejiang Cancer Hospital

Investigators

  • Principal Investigator: Ping Huang, Zhejiang Cancer Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

September 16, 2022

Primary Completion (Anticipated)

September 16, 2025

Study Completion (Anticipated)

December 30, 2025

Study Registration Dates

First Submitted

September 18, 2022

First Submitted That Met QC Criteria

September 18, 2022

First Posted (Actual)

September 22, 2022

Study Record Updates

Last Update Posted (Actual)

September 27, 2022

Last Update Submitted That Met QC Criteria

September 23, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZCHBC022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Decide whether to share individual participant data after clinical research reaches a certain stage

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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