NCT03088163UnknownNot Applicable
The Value of DWI-MRI(Diffusion-weighted Imaging) in Evaluating the Early Efficacy of Liver Metastasis in Colorectal Cancer
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Fudan University
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Response rate
Study Overview
Brief Summary
The study is designed to evaluate the value of DWI-MRI (Diffusion weighted magnetic resonance imaging) in predicting the efficacy of liver metastases after chemotherapy in colorectal cancer.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Device Feasibility
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •aged ≥18 years with histologically or cytologically confirmed advanced colorectal adenocarcinoma
- •Eastern Cooperative Oncology Group performance status of 0 to 2
- •life expectancy of ≥ 3 months
- •at least one measurable liver metastatic lesion in MRI (≥10mm)
- •have adequate bone marrow, hepatic, and renal function
- •previously received no palliative chemotherapy
Exclusion Criteria
- •patients with previous chronic inflammatory bowel disease, chronic diarrhea or recurrent bowel obstruction
- •patients with symptomatic brain metastases
- •active clinical severe infection
- •have contraindication of MRI screening
Outcomes
Primary Outcomes
Response rate
Time Frame: 2 months
the response rate predicted by DWI-MRI
Secondary Outcomes
- Progression free survival(2 months)
- Overall survival(2 months)
Investigators
Weijian Guo
Fudan University Shanghai Cancer Center
Fudan University
Study Sites (1)
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