NCT03088163

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2016

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

March 17, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 23, 2017

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2018

Completed
Last Updated

March 23, 2017

Status Verified

March 1, 2017

Enrollment Period

2 years

First QC Date

March 17, 2017

Last Update Submit

March 22, 2017

Conditions

DWI-MRI

Outcome Measures

Primary Outcomes (1)

  • Response rate

    the response rate predicted by DWI-MRI

    2 months

Secondary Outcomes (2)

  • Progression free survival

    2 months

  • Overall survival

    2 months

Study Arms (1)

DWI-MRI

EXPERIMENTAL
Device: Diffusion weighted magnetic resonance imaging

Interventions

Diffusion weighted magnetic resonance imagingDEVICE

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.

Also known as: DWI-MRI
DWI-MRI

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fudan University Cancer Hospital

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

MeSH Terms

Interventions

Diffusion Magnetic Resonance Imaging

Intervention Hierarchy (Ancestors)

Magnetic Resonance ImagingTomographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Weijian Guo

    Fudan University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Weijian Guo

CONTACT

8621-64175590mingzhuhuang0718@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DEVICE FEASIBILITY
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Fudan University Shanghai Cancer Center

Study Record Dates

First Submitted

March 17, 2017

First Posted

March 23, 2017

Study Start

August 1, 2016

Primary Completion

August 1, 2018

Study Completion

August 1, 2018

Last Updated

March 23, 2017

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)