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Clinical Trials/NCT03088163
NCT03088163UnknownNot Applicable

The Value of DWI-MRI(Diffusion-weighted Imaging) in Evaluating the Early Efficacy of Liver Metastasis in Colorectal Cancer

Fudan University1 site in 1 country100 target enrollmentStarted: August 2016Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
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

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Weijian Guo

Fudan University Shanghai Cancer Center

Fudan University

Study Sites (1)

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