Cancer of PancreasNCT02682394
Evaluation of Pancreatic Steatosis in Patients With Cancer of Pancreas
An observational study of Cancer of Pancreas, run by Soroka University Medical Center at 1 site in Israel.
Trial summary
Prognostic Importance of Quantitative Magnetic Resonance Imaging for Evaluation of Pancreatic Steatosis in Patients with Pancreatic Cancer Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer of Pancreas
- How many people
- 30 participants
- Where
- 1 siteIsrael
- Study dates
- Sep 2015to Oct 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 30 patients diagnosed with any pancreatic cancer, in any stage, before treatment.
Who may be able to join
- patients diagnosed with any pancreatic cancer, in any stage, before treatment.
- >18 y.o
Who cannot join
- claustrophobia
- GFR<30
- patients with non mri compatible devices (e.g. orthopaedic external fixation system)
- After chemotherapy treatment or surgical procedure
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Soroka university medical center
Beersheba
Vladimir Borodetsky, MD, +972547428882, zivova1982@gmail.com
Irina Lazerev, MD, +972526226458, irinalaz@clalit.org.il
About this study
Official title: 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
Read the 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.
- Conditions
- Cancer of Pancreas
- Keywords
- Cancer of pancreas, steatosis, MRI
- Medical subject headings
- Pancreatic Neoplasms, Fatty Liver
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at 24 hours before chemotherapy starting
Blood levels of free DNA
Correlation of free DNA level and metastatic spread.
Measured: The blood sample taken 15 minutes prior to MRI study, at time of IV access.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2016 (estimated)
- Study startSep 2015
- Primary completionSep 2017 (estimated)
- Study completionOct 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer of PancreasStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Soroka University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alla Khashper, MD, Principal investigator, Soroka University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02682394
- Sponsor's protocol ID
- SOR0216-15CTIL
- Status last verified
- Sep 2015
- First submitted
- 28 Dec 2015
- Last updated
- 15 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Importance of Quantitative Magnetic Resonance Imaging for Evaluation of Pancreatic Steatosis in Patients With Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT02682394
- Acronym / sponsor ID
- SOR0216-15CTIL
- Conditions
- Cancer of Pancreas
- Keywords
- Cancer of pancreas, steatosis, MRI
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Soroka University Medical CenterUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Sep 2017 (estimated)
- Study completion
- Oct 2017 (estimated)
- First posted
- 15 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 30 patients diagnosed with any pancreatic cancer, in any stage, before treatment.
Key inclusion criteria (2 listed)
- patients diagnosed with any pancreatic cancer, in any stage, before treatment.
- >18 y.o
Key exclusion criteria (4 listed)
- claustrophobia
- GFR<30
- patients with non mri compatible devices (e.g. orthopaedic external fixation system)
- After chemotherapy treatment or surgical procedure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2016.
- Ministry of Health, Israel. Israel Cancer Registry.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alla Khashper, MD principal investigator
Soroka University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer of Pancreas, run by Soroka University Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Vladimir Borodetsky, MD (+972547428882, zivova1982@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of fat in pancreas measured in the head, body and tail excluding the lesion area. (time frame: at 24 hours before chemotherapy starting). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2016.