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

March 22, 2017 updated by: Weijian Guo, Fudan University

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

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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

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

Study Locations

  • China
    • Shanghai
      • ShangHai, Shanghai, China, 200032
        • Recruiting
        • Fudan University Cancer Hospital

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

Description

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

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

  • Primary Purpose: Device Feasibility
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: DWI-MRI
Device: Diffusion weighted magnetic resonance imaging
The enrolled colorectal liver metastases patients will receive DWI-MRI screening to evaluate the liver metastases before the chemotherapy, after the first cycle of chemotherapy and in the regular efficacy evaluation time, respectively.
Other Names:
  • DWI-MRI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Response rate
Time Frame: 2 months
the response rate predicted by DWI-MRI
2 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Progression free survival
Time Frame: 2 months
2 months
Overall survival
Time Frame: 2 months
2 months

Collaborators and Investigators

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

Sponsor

Fudan University

Investigators

  • Principal Investigator: Weijian Guo, Fudan University

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 (Actual)

August 1, 2016

Primary Completion (Anticipated)

August 1, 2018

Study Completion (Anticipated)

August 1, 2018

Study Registration Dates

First Submitted

March 17, 2017

First Submitted That Met QC Criteria

March 22, 2017

First Posted (Actual)

March 23, 2017

Study Record Updates

Last Update Posted (Actual)

March 23, 2017

Last Update Submitted That Met QC Criteria

March 22, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FDZL-MRinCLM

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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