NCT02682394

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2015

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2015

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 28, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 15, 2016

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
Last Updated

February 15, 2016

Status Verified

September 1, 2015

Enrollment Period

2 years

First QC Date

December 28, 2015

Last Update Submit

February 12, 2016

Conditions

Cancer of Pancreas

Keywords

Cancer of pancreassteatosisMRI

Outcome Measures

Primary Outcomes (2)

  • 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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Soroka university medical center

Beersheba, Israel

RECRUITING

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

Cell-free DNA, CFD

MeSH Terms

Conditions

Pancreatic NeoplasmsFatty Liver

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System DiseasesLiver Diseases

Study Officials

  • Alla Khashper, MD

    Soroka University Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Vladimir Borodetsky, MD

CONTACT

+972547428882zivova1982@gmail.com

Irena Lazerev, MD

CONTACT

+972526226458irinalaz@clalit.org.il

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 28, 2015

First Posted

February 15, 2016

Study Start

September 1, 2015

Primary Completion

September 1, 2017

Study Completion

October 1, 2017

Last Updated

February 15, 2016

Record last verified: 2015-09

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)