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 Contact

Study Contact Backup

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200025
        • Radiology Department, Ruijing Hospital, Shanghai Jiaotong University
        • Contact:
        • Principal Investigator:
          • Fuhua Yan, MD, PhD
      • Shanghai, Shanghai, China, 200032
        • Radiology Department, Cancer Hospital, Fuandan University
        • Contact:
        • Principal Investigator:
          • Weijun Peng, MD, PhD
      • Shanghai, Shanghai, China, 200032
        • Radiology Department, Zhongshan Hospital, Fudan University
        • Contact:
        • Principal Investigator:
          • Mengsu Zeng, MD, PhD
      • Shanghai, Shanghai, China, 200040
        • Radiology Department, Huadong Hospital, Fudan University
        • Contact:
        • Principal Investigator:
          • Yanqing Hua, MD, PhD
      • Shanghai, Shanghai, China, 200040
        • Radiology Department, Huashan Hospital, Fudan University
        • Contact:
        • Principal Investigator:
          • Xiaoyuan Feng, MD, PhD
      • Shanghai, Shanghai, China, 200433
        • Radiology Department, Changhai Hospital Affiliated to the Second Military Medical University
        • Contact:
        • Principal Investigator:
          • Jianping Lu, MD, Phd

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

Meng Su Zeng

Collaborators

Changhai Hospital
Huashan Hospital
Ruijin Hospital
Shanghai Cancer Hospital, China
Huadong Hospital

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

Keywords

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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