NCT01455610

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
140

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2011

Shorter than P25 for all trials

Geographic Reach
1 country

6 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2011

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

October 18, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 20, 2011

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
Last Updated

October 20, 2011

Status Verified

October 1, 2011

Enrollment Period

1 year

First QC Date

October 18, 2011

Last Update Submit

October 19, 2011

Conditions

Adenocarcinoma of Head of Pancreas

Keywords

Computed tomographyContrast enhancementPancreasCancerResectability

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Out-patients or in-patients,with(or suspected) pancreatic head cancer, both have MDCT examinaton and receive surgery treatment

You may qualify if:

  • Patients with (or suspected) pancreatic head cancer
  • Being examined by contrasted-enhanced MDCT
  • Receiving surgical treatment (including palliative surgery) in all research centers

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Radiology Department, Ruijing Hospital, Shanghai Jiaotong University

Shanghai, Shanghai Municipality, 200025, China

Location

Radiology Department, Cancer Hospital, Fuandan University

Shanghai, Shanghai Municipality, 200032, China

Location

Radiology Department, Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, 200032, China

Location

Radiology Department, Huadong Hospital, Fudan University

Shanghai, Shanghai Municipality, 200040, China

Location

Radiology Department, Huashan Hospital, Fudan University

Shanghai, Shanghai Municipality, 200040, China

Location

Radiology Department, Changhai Hospital Affiliated to the Second Military Medical University

Shanghai, Shanghai Municipality, 200433, China

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Mengsu Zeng, MD, PhD

    Radiology Department, Zhongshan Hospital of Fudan University

    STUDY CHAIR

  • 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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mengsu Zeng, MD, PhD

CONTACT

+86-021-64041990-2130zengmengsu@gmail.com

Xiuzhong Yao, MD, PhD

CONTACT

+86-021-64041990-5425fjqzyaoxz02@163.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Mengsu Zeng, MD & Ph.D,Chairman & Professor,Department of Radiology

Study Record Dates

First Submitted

October 18, 2011

First Posted

October 20, 2011

Study Start

October 1, 2011

Primary Completion

October 1, 2012

Study Completion

October 1, 2012

Last Updated

October 20, 2011

Record last verified: 2011-10

Locations

CN(6)