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Evaluation of Pancreatic Steatosis in Patients With Cancer of Pancreas

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ClinicalTrials.gov Identifier: NCT02682394
Recruitment Status : Unknown
Verified September 2015 by Soroka University Medical Center.
Recruitment status was:  Recruiting
First Posted : February 15, 2016
Last Update Posted : February 15, 2016
Sponsor:
Information provided by (Responsible Party):
Soroka University Medical Center

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

Condition or disease
Cancer of Pancreas

Detailed 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.

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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prognostic Importance of Quantitative Magnetic Resonance Imaging for Evaluation of Pancreatic Steatosis in Patients With Pancreatic Cancer
Study Start Date : September 2015
Estimated Primary Completion Date : September 2017
Estimated Study Completion Date : October 2017

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 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.

  2. 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.


Biospecimen Retention:   Samples With DNA
Cell-free DNA, CFD


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
30 patients diagnosed with any pancreatic cancer, in any stage, before treatment.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02682394


Contacts
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Contact: Vladimir Borodetsky, MD +972547428882 zivova1982@gmail.com
Contact: Irena Lazerev, MD +972526226458 irinalaz@clalit.org.il

Locations
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Israel
Soroka university medical center Recruiting
Beer Sheva, Israel, =
Contact: Vladimir Borodetsky, MD    +972547428882    zivova1982@gmail.com   
Contact: Irina Lazerev, MD    +972526226458    irinalaz@clalit.org.il   
Principal Investigator: Alla Khashper, MD         
Sponsors and Collaborators
Soroka University Medical Center
Investigators
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Principal Investigator: Alla Khashper, MD Soroka University Medical Center

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Responsible Party: Soroka University Medical Center
ClinicalTrials.gov Identifier: NCT02682394     History of Changes
Other Study ID Numbers: SOR0216-15CTIL
First Posted: February 15, 2016    Key Record Dates
Last Update Posted: February 15, 2016
Last Verified: September 2015
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Soroka University Medical Center:
Cancer of pancreas
steatosis
MRI
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Pancreatic Diseases
Pancrelipase
Fatty Liver
Liver Diseases
Digestive System Diseases
Endocrine System Diseases
Gastrointestinal Agents