- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02553031
Application of MR-PET in Colorectal Cancer
May 14, 2017 updated by: National Taiwan University Hospital
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Observational
Enrollment (Anticipated)
100
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
-
-
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Taipei, Taiwan
- Recruiting
- National Taiwan University Hospital
-
Contact:
- Ting-Fang Shih, MD
- Phone Number: 65568 +886-2-23123456
- Email: ttfshih@ntu.edu.tw
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-
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
20 years to 90 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
This is a prospective cohort study.
Patients with 50 newly diagnosed colorectal cancers and 50 patients with suspicious recurrent colorectal cancers will be enrolled.
Description
Inclusion Criteria:
- Group 1: Patients with newly diagnosed colorectal cancers
- Group 2: Patients with suspicious recurrent colorectal cancers
Exclusion Criteria:
- Age <20 or >90 years old
- Contraindication for MRI: claustrophobia or MR non-compatible devices
- Contraindication for MR contrast medium: severe adverse reaction or impaired renal function (Cre > 2.0)
- History of other malignancy
- Prior arthroplasty of hip (may cause artifacts on MRI)
- Pregnancy
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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
The recurrence rate at 1 year after surgery
Time Frame: 1 year
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
The overall survival at 1 year after surgery
Time Frame: 1 year
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Ting-Fang Shih, M.D., Department of Medical Imaging, National Taiwan University Hospital.
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
July 1, 2014
Primary Completion (Anticipated)
December 1, 2017
Study Completion (Anticipated)
May 1, 2018
Study Registration Dates
First Submitted
September 10, 2015
First Submitted That Met QC Criteria
September 16, 2015
First Posted (Estimate)
September 17, 2015
Study Record Updates
Last Update Posted (Actual)
May 16, 2017
Last Update Submitted That Met QC Criteria
May 14, 2017
Last Verified
May 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 201403082MIND
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.