Resectability of Pancreatic Head Cancer by Contrast-enhan... | NCT01455610

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

NCT01455610

Sponsor

Meng Su Zeng

Status

Unknown status

Last Update Posted

Oct 20, 2011Estimated

Enrollment

140Estimated

Phase

Not provided

Conditions

Adenocarcinoma of Head of Pancreas

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2011

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2011

Primary Completion Date

Oct 2012Estimated

Completion Date

Oct 2012Estimated

First Submitted Date

Oct 18, 2011

First Submission Date that Met QC Criteria

Oct 19, 2011

First Posted Date

Oct 20, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 19, 2011

Last Update Posted Date

Oct 20, 2011Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Meng Su Zeng, Mengsu Zeng, MD & Ph.D,Chairman & Professor,Department of Radiology, Shanghai Zhongshan HospitalSponsor-Investigator

Lead Sponsor

Meng Su ZengOTHER

Collaborators

Name	Class
Changhai Hospital	OTHER
Shanghai Cancer Hospital, China	OTHER
Ruijin Hospital	OTHER
Huashan Hospital

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

140Estimated

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Mengsu Zeng, MD, PhD	Contact	+86-021-64041990-2130		zengmengsu@gmail.com
Xiuzhong Yao, MD, PhD	Contact	+86-021-64041990-5425		fjqzyaoxz02@163.com

Overall Officials

Name	Affiliation	Role
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

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Radiology Department, Ruijing Hospital, Shanghai Jiaotong University		Shanghai	Shanghai Municipality	200025	China

Condition Browse Module

MeSH Terms

ID	Term
D009369	Neoplasms

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided