Evaluation of Pancreatic Steatosis in Patients With Cance... | NCT02682394

Studies
Evaluation of Pancreatic Steatosis in Patients With Cancer of Pancreas

NCT02682394

Sponsor

Soroka University Medical Center

Status

Unknown status

Last Update Posted

Feb 15, 2016Estimated

Enrollment

30Estimated

Phase

Not provided

Conditions

Cancer of Pancreas

Interventions

Not provided

Countries

Israel

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

Sep 2015

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

Sep 2015

Primary Completion Date

Sep 2017Estimated

Completion Date

Oct 2017Estimated

First Submitted Date

Dec 28, 2015

First Submission Date that Met QC Criteria

Feb 12, 2016

First Posted Date

Feb 15, 2016Estimated

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

Feb 12, 2016

Last Update Posted Date

Feb 15, 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

Prognostic Importance of Quantitative Magnetic Resonance Imaging for Evaluation of Pancreatic Steatosis in Patients with Pancreatic Cancer

Detailed Description

Finding patients with pancreatic cancer (in all stages), before any treatment.
Non invasively quantify fatty infiltration of pancreas using, MRI DIXON Scan in pancreatic cancer patient relatively to liver.
Measuring cell-free blood DNA in those patients for evaluating the aggressiveness of the disease.
Quantify the prognostic significance of pancreatic steatosis in comparison with clinical and pathological prognostic indexes used today.

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

Retention

Enrollment

30Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of fat in pancreas measured in the head, body and tail excluding the lesion area.	measuring Pancreatic Steatosis in patients with pancreatic cancer using MRI DIXON scan, at 24 hours before chemotherapy starting.	at 24 hours before chemotherapy starting
Blood levels of free DNA	Correlation of free DNA level and metastatic spread.	The blood sample taken 15 minutes prior to MRI study, at time of IV access.

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients diagnosed with any pancreatic cancer, in any stage, before treatment.
>18 y.o

Exclusion Criteria:

claustrophobia
GFR<30
patients with non mri compatible devices (e.g. orthopaedic external fixation system)
After chemotherapy treatment or surgical procedure

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

30 patients diagnosed with any pancreatic cancer, in any stage, before treatment.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Vladimir Borodetsky, MD	Contact	+972547428882		zivova1982@gmail.com
Irena Lazerev, MD	Contact	+972526226458		irinalaz@clalit.org.il

Overall Officials

Name	Affiliation	Role
Alla Khashper, MD	Soroka University Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Soroka university medical center	Recruiting	Beersheba			Israel

Label	URL
Ministry of Health, Israel. Israel Cancer Registry.	View source

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010190	Pancreatic Neoplasms
D005234	Fatty Liver

Ancestor Terms

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

Browse Leaves

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Browse Branches

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