- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01455610
Resectability of Pancreatic Head Cancer by Contrast-enhanced MDCT:a Multi-center Study
October 19, 2011 updated by: Meng Su Zeng
Preoperative Evaluation of Resectability of Pancreatic Head Cancer by Contrast-enhanced MDCT:a Multi-center Study
The purpose of this multicenter and double-blind clinical trial is to prospectively assess the sensitivity, specificity, negative predictive value, positive predictive value, and accuracy in respectability of pancreatic head cancer with contrasted-enhanced MDCT and its various post processing techniques, taking operational and pathological records as the gold standard.
Study Overview
Status
Unknown
Conditions
Study Type
Observational
Enrollment (Anticipated)
140
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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Shanghai
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Shanghai, Shanghai, China, 200025
- Radiology Department, Ruijing Hospital, Shanghai Jiaotong University
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Shanghai, Shanghai, China, 200032
- Radiology Department, Cancer Hospital, Fuandan University
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Shanghai, Shanghai, China, 200032
- Radiology Department, Zhongshan Hospital, Fudan University
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Shanghai, Shanghai, China, 200040
- Radiology Department, Huadong Hospital, Fudan University
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Shanghai, Shanghai, China, 200040
- Radiology Department, Huashan Hospital, Fudan University
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Shanghai, Shanghai, China, 200433
- Radiology Department, Changhai Hospital Affiliated to the Second Military Medical University
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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
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Out-patients or in-patients,with(or suspected) pancreatic head cancer, both have MDCT examinaton and receive surgery treatment
Description
Inclusion Criteria:
- Patients with (or suspected) pancreatic head cancer
- Being examined by contrasted-enhanced MDCT
- Receiving surgical treatment (including palliative surgery) in all research centers
Exclusion Criteria:
- Patients having (or suspected) pregnancy or breast-feeding
- Patients having allergic reactions to iodinated contrast agents or Hypersensitivity reactions to allergens(including drugs)
- Patients receiving ERCP before contrasted-enhanced MDCT examination
- Patients without surgery because of a high degree of surgical risk
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
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Chair: Mengsu Zeng, MD, PhD, Radiology Department, Zhongshan Hospital of Fudan University
- Principal Investigator: Jianping Lu, MD,PhD, Radiology Department, Changhai Hospital Affiliated to Second Military Medical University
- Principal Investigator: Weijun Peng, MD, PhD, Radiology Department, Cancer Hospital Affiliated to Fudan University
- Principal Investigator: Fuhua Yan, MD, PhD, Radiology Department, Ruijin Hospital Affiliated to Shanghai Jiaotong University, China
- Principal Investigator: Xiaoyuan Feng, MD, PhD, Radiology Department, Huashan Hospital, Fudan University, China
- Principal Investigator: Yanqing Hua, MD, PhD, Radiology Department, Huadong Hospital Affiliated to Fudan University, China
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
October 1, 2011
Primary Completion (ANTICIPATED)
October 1, 2012
Study Completion (ANTICIPATED)
October 1, 2012
Study Registration Dates
First Submitted
October 18, 2011
First Submitted That Met QC Criteria
October 19, 2011
First Posted (ESTIMATE)
October 20, 2011
Study Record Updates
Last Update Posted (ESTIMATE)
October 20, 2011
Last Update Submitted That Met QC Criteria
October 19, 2011
Last Verified
October 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ZMS-001
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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