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

NCT ID: NCT05550090

Last Updated: 2022-09-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-09-16

Study Completion Date

2025-12-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Metastatic Breast Cancer in the Liver

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with liver metastasis from breast cancer requiring antitumor therapy

Patients with liver metastasis from breast cancer requiring antitumor therapy

Chemotherapy

Intervention Type 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.

Interventions

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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.

Intervention Type DRUG

Other Intervention Names

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Chemotherapy can be combined with targeted or immunotherapy or endocrine therapy.

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Zhejiang Cancer Hospital

OTHER

Sponsor Role lead

Responsible Party

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Huang Ping

Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ping Huang

Role: PRINCIPAL_INVESTIGATOR

Zhejiang Cancer Hospital

Locations

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Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Ping Huang

Role: CONTACT

+8613685766632

Xiaojia Wang

Role: CONTACT

+8613906500190

Facility Contacts

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Ping Huang

Role: primary

+86-13685766632

References

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Other Identifiers

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ZCHBC022

Identifier Type: -

Identifier Source: org_study_id

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