Evaluation of Pancreatic Steatosis in Patients With Cancer of Pancreas

February 12, 2016 updated by: Soroka University Medical Center

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

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

Study Overview

Status

Unknown

Conditions

Cancer of Pancreas

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.

Study Type

Observational

Enrollment (Anticipated)

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Israel
- - Beer Sheva, Israel
    - Recruiting
    - Soroka University Medical Center
    - Contact:
      
      Vladimir Borodetsky, MD
      
      Phone Number: +972547428882
      
      Email: zivova1982@gmail.com
    - Contact:
      
      Irina Lazerev, MD
      
      Phone Number: +972526226458
      
      Email: irinalaz@clalit.org.il
    - Principal Investigator:
      
      Alla Khashper, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of fat in pancreas measured in the head, body and tail excluding the lesion area. Time Frame: at 24 hours before chemotherapy starting	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 Time Frame: The blood sample taken 15 minutes prior to MRI study, at time of IV access.	Correlation of free DNA level and metastatic spread.	The blood sample taken 15 minutes prior to MRI study, at time of IV access.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Soroka University Medical Center

Investigators

Principal Investigator: Alla Khashper, MD, Soroka University Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2015

Primary Completion (Anticipated)

September 1, 2017

Study Completion (Anticipated)

October 1, 2017

Study Registration Dates

First Submitted

December 28, 2015

First Submitted That Met QC Criteria

February 12, 2016

First Posted (Estimate)

February 15, 2016

Study Record Updates

Last Update Posted (Estimate)