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

DWI-MRI Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03088163
• Other study ID #: FDZL-MRinCLM
• Status: Recruiting
• Phase: N/A
• First received: March 17, 2017
• Last updated: March 22, 2017
• Start date: August 2016
• Est. completion date: August 2018

Study information

• Verified date: March 2017
• Source: Fudan University
• Contact: Weijian Guo
• Phone: 8621-64175590
• Email: mingzhuhuang0718[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: August 2018
• Est. primary completion date: August 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Neoplasms
• DWI-MRI

Intervention

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.

Locations

Country	Name	City	State
China	Fudan University Cancer Hospital	ShangHai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response rate	the response rate predicted by DWI-MRI	2 months
Secondary	Progression free survival		2 months
Secondary	Overall survival		2 months