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Resectability of Pancreatic Head Cancer by Contrast-enhanced MDCT:a Multi-center Study

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2011 by Meng Su Zeng, Shanghai Zhongshan Hospital.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01455610
First Posted: October 20, 2011
Last Update Posted: October 20, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Changhai Hospital
Shanghai Cancer Hospital, China
Ruijin Hospital
Huashan Hospital
Huadong Hospital
Information provided by (Responsible Party):
Meng Su Zeng, Shanghai Zhongshan Hospital
  Purpose
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.

Condition
Adenocarcinoma of Head of Pancreas

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Preoperative Evaluation of Resectability of Pancreatic Head Cancer by Contrast-enhanced MDCT:a Multi-center Study

Further study details as provided by Meng Su Zeng, Shanghai Zhongshan Hospital:

Estimated Enrollment: 140
Study Start Date: October 2011
Estimated Study Completion Date: October 2012
Estimated Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01455610


Contacts
Contact: Mengsu Zeng, MD, PhD +86-021-64041990-2130 zengmengsu@gmail.com
Contact: Xiuzhong Yao, MD, PhD +86-021-64041990-5425 fjqzyaoxz02@163.com

Locations
China, Shanghai
Radiology Department, Ruijing Hospital, Shanghai Jiaotong University Not yet recruiting
Shanghai, Shanghai, China, 200025
Contact: Fuhua Yan, MD, PhD    +86-13764236797    Lin-xiaozhu-rj@hotmail.com   
Principal Investigator: Fuhua Yan, MD, PhD         
Radiology Department, Cancer Hospital, Fuandan University Not yet recruiting
Shanghai, Shanghai, China, 200032
Contact: Weijun Peng, Md, PhD    +86-13564682870    Huizhu171717@163.com   
Principal Investigator: Weijun Peng, MD, PhD         
Radiology Department, Zhongshan Hospital, Fudan University Not yet recruiting
Shanghai, Shanghai, China, 200032
Contact: Mengsu Zeng, MD, PhD    +86-021-64041990-2130    zengmengsu@gmail.com   
Principal Investigator: Mengsu Zeng, MD, PhD         
Radiology Department, Huadong Hospital, Fudan University Not yet recruiting
Shanghai, Shanghai, China, 200040
Contact: Yanqing Hua, MD, PhD    +86-13774234090    13774234090@163.com   
Principal Investigator: Yanqing Hua, MD, PhD         
Radiology Department, Huashan Hospital, Fudan University Not yet recruiting
Shanghai, Shanghai, China, 200040
Contact: Xiaoyuan Feng, MD, PhD    +86-13601659304    liangzh@vip.163.com   
Principal Investigator: Xiaoyuan Feng, MD, PhD         
Radiology Department, Changhai Hospital Affiliated to the Second Military Medical University Not yet recruiting
Shanghai, Shanghai, China, 200433
Contact: Jianping Lu, MD, PhD    +86-13701775219    13701775219@163.com   
Principal Investigator: Jianping Lu, MD, Phd         
Sponsors and Collaborators
Meng Su Zeng
Changhai Hospital
Shanghai Cancer Hospital, China
Ruijin Hospital
Huashan Hospital
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
  More Information

Responsible Party: Meng Su Zeng, Mengsu Zeng, MD & Ph.D,Chairman & Professor,Department of Radiology, Shanghai Zhongshan Hospital
ClinicalTrials.gov Identifier: NCT01455610     History of Changes
Other Study ID Numbers: ZMS-001
First Submitted: October 18, 2011
First Posted: October 20, 2011
Last Update Posted: October 20, 2011
Last Verified: October 2011

Keywords provided by Meng Su Zeng, Shanghai Zhongshan Hospital:
Computed tomography
Contrast enhancement
Pancreas
Cancer
Resectability

Additional relevant MeSH terms:
Adenocarcinoma
Head and Neck Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms by Site