Evaluation of Prognosis With Integrated MRI/PET in Patien... | NCT02550847

Studies
Evaluation of Prognosis With Integrated MRI/PET in Patients With Pancreatic Cancer

NCT02550847

Sponsor

National Taiwan University Hospital

Status

Unknown status

Last Update Posted

Apr 14, 2016Estimated

Enrollment

100Estimated

Phase

Not provided

Conditions

Pancreatic Cancer

Interventions

The imaging biomarkers determined by MR-PET

Countries

Taiwan

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

Apr 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2014

Primary Completion Date

Apr 2016Estimated

Completion Date

Aug 2016Estimated

First Submitted Date

Sep 8, 2015

First Submission Date that Met QC Criteria

Sep 15, 2015

First Posted Date

Sep 16, 2015Estimated

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

Apr 12, 2016

Last Update Posted Date

Apr 14, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

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 aim of this study was to evaluate MR/PET with both functional and molecular imaging on the prediction of prognosis in patients with suspected pancreatic cancer.

Detailed Description

The results of MR/PET will be compared prospectively to dedicated MDCT or MR imaging, pathologic results, and clinical outcomes to assess the value of MR/PET in pancreatic cancers.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

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

100Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
The imaging biomarkers determined by MR-PET	Device	The aim of this study was to evaluate MR/PET with both functional and molecular imaging on the prediction of prognosis in patients with suspected pancreatic cancer.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The tumor recurrence rate after operation at 6 months		6 months

Secondary Outcomes

Measure	Description	Time Frame
The overall survival after operation at 6 months		6 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Diagnosed as pancreatic cancer
Between 20~90 years old
ECOG 0-2
Normal renal function
Measurable tumor size (>1cm)

Exclusion Criteria:

Contraindication for MRI exam
Claustrophobia
Renal insufficiency
Other malignancy
Pregnancy and lactating women

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

This study will include 100 consecutive patients (around 100 newly diagnosed patients per year at NTUH) presenting with suspect pancreatic cancer for treatment.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ting-Fang Shih, MD	Contact	+886-2-23123456	65568	ttfshih@ntu.edu.tw

Overall Officials

Name	Affiliation	Role
Ting-Fang Shih, MD	Department of Medical Imaging, National Taiwan University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
National Taiwan University Hospital	Recruiting	Taipei			Taiwan

Condition Browse Module

MeSH Terms

ID	Term
D010190	Pancreatic Neoplasms

Ancestor Terms

ID	Term
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D004701	Endocrine Gland Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided