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NCT02682394 Clinical Trial

Evaluation of Pancreatic Steatosis in Patients With Cancer of Pancreas

Cancer of Pancreas Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02682394
Other study ID # SOR0216-15CTIL
Secondary ID
Status Recruiting
Phase N/A
First received December 28, 2015
Last updated February 12, 2016
Start date September 2015
Est. completion date October 2017

Study information
Verified date September 2015
Source Soroka University Medical Center
Contact Vladimir Borodetsky, MD
Phone +972547428882
Email zivova1982@gmail.com
Is FDA regulated No
Health authority Israel: Ministry of Health
Study type Observational

Clinical Trial Summary

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

Description:

1. Finding patients with pancreatic cancer (in all stages), before any treatment.

2. Non invasively quantify fatty infiltration of pancreas using, MRI DIXON Scan in pancreatic cancer patient relatively to liver.

3. Measuring cell-free blood DNA in those patients for evaluating the aggressiveness of the disease.

4. Quantify the prognostic significance of pancreatic steatosis in comparison with clinical and pathological prognostic indexes used today.

Recruitment information / eligibility
Status Recruiting
Enrollment 30
Est. completion date October 2017
Est. primary completion date September 2017
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Israel Soroka university medical center Beer Sheva

Sponsors (1)
Lead Sponsor Collaborator
Soroka University Medical Center

Country where clinical trial is conducted

Israel, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 No
Primary 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. No
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