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Trial Title:
Dynamic Contrast-enhanced MRI Combined With IVIM-DWI for Early Prediction of Chemosensitivity in Liver MBC
NCT ID:
NCT05550090
Condition:
Metastatic Breast Cancer in the Liver
Conditions: Official terms:
Breast Neoplasms
Immunomodulating Agents
Conditions: Keywords:
Liver metastasis
Breast cancer
Efficacy prediction
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Drug
Intervention name:
Chemotherapy
Description:
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.
Arm group label:
Patients with liver metastasis from breast cancer requiring antitumor therapy
Other name:
Chemotherapy can be combined with targeted or immunotherapy or endocrine therapy.
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.
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.
Criteria for eligibility:
Study pop:
Patients with liver metastasis from breast cancer requiring at least 2 cycles of systemic
chemotherapy
Sampling method:
Non-Probability Sample
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Zhejiang Cancer Hospital
Address:
City:
Hangzhou
Zip:
310022
Country:
China
Status:
Recruiting
Contact:
Last name:
Ping Huang
Phone:
+86-13685766632
Email:
zlyyhp@163.com
Investigator:
Last name:
Ping Huang
Email:
Principal Investigator
Start date:
September 16, 2022
Completion date:
December 30, 2025
Lead sponsor:
Agency:
Zhejiang Cancer Hospital
Agency class:
Other
Source:
Zhejiang Cancer Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05550090
