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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02553031
Other study ID # 201403082MIND
Secondary ID
Status Recruiting
Phase N/A
First received September 10, 2015
Last updated May 14, 2017
Start date July 2014
Est. completion date May 2018

Study information

Verified date May 2017
Source National Taiwan University Hospital
Contact Ting-Fang Shih, MD
Phone +886-2-23123456
Email ttfshih@ntu.edu.tw
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study will explore the potential value in proper therapeutic decision and clinical outcome prediction by using integrated MR-PET system and advanced MR techniques in patients with colorectal cancer.


Description:

This research expect that the image techniques and experience in this cancer group may be valuable and helpful for others. With advantage of MR-PET in better soft tissue delineation/functional information and less radiation dose than PET-CT, the ultimate goal in both research and clinical application is to establish new diagnostic standard and management guideline by MR-PET, which can further improve clinical outcome and disease prognosis in patients colorectal cancer.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date May 2018
Est. primary completion date December 2017
Accepts healthy volunteers No
Gender All
Age group 20 Years to 90 Years
Eligibility Inclusion Criteria:

1. Group 1: Patients with newly diagnosed colorectal cancers

2. Group 2: Patients with suspicious recurrent colorectal cancers

Exclusion Criteria:

1. Age <20 or >90 years old

2. Contraindication for MRI: claustrophobia or MR non-compatible devices

3. Contraindication for MR contrast medium: severe adverse reaction or impaired renal function (Cre > 2.0)

4. History of other malignancy

5. Prior arthroplasty of hip (may cause artifacts on MRI)

6. Pregnancy

Study Design


Related Conditions & MeSH terms


Intervention

Device:
The imaging biomarkers determined by MR-PET
This study will explore the potential value in proper therapeutic decision and clinical outcome prediction by using integrated MR-PET system and advanced MR techniques in patients with colorectal cancer.

Locations

Country Name City State
Taiwan National Taiwan University Hospital Taipei

Sponsors (1)

Lead Sponsor Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary The recurrence rate at 1 year after surgery 1 year
Secondary The overall survival at 1 year after surgery 1 year
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