Functional Magnetic Resonance Imaging of Pancreatic Cancer: a Feasibility and Reproducibility Study
NCT ID: NCT01995240
Last Updated: 2017-03-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
23 participants
INTERVENTIONAL
2013-04-30
2017-02-28
Brief Summary
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Detailed Description
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Novel predictive markers are needed to determine treatment efficacy in pancreatic cancer at an early stage. Preferably, these markers could be determined non-invasively and provide insight into the biology of pancreatic cancer. Several MR techniques can serve for this purpose. However, optimalisation of these techniques is needed and their reproducibility should be assessed.
Objective of the study:
To optimize DCE-MRI, T2\* MRI and DWI in pancreatic cancer at 3T and investigate its reproducibility.
Study design:
In the first part of the study, patients with pancreatic cancer will undergo an MR measurement protocol once at 3T, to optimize MR techniques (DCE-MRI, T2\* MRI and DWI). In the second part of the study, to assess reproducibility patients will undergo the MR measurement protocol twice within one week before start of any treatment.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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Optimization
For optimization of the protocol patients will undergo one DCE-MRI (Gadobutrol), T2\* MRI and DWI MRI scan.
Gadobutrol
0.1 ml/kg Gadovist is administered at 5 ml/s followed by a 15 ml saline flush
Reproducibility
For determination of the reproducibility patients will undergo two DCE-MRI (Gadobutrol), T2\* MRI and DWI MRI scans within one week.
Gadobutrol
0.1 ml/kg Gadovist is administered at 5 ml/s followed by a 15 ml saline flush
Interventions
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Gadobutrol
0.1 ml/kg Gadovist is administered at 5 ml/s followed by a 15 ml saline flush
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Any tumor with a size ≥ 1cm
* WHO-performance score 0-2
* Written informed consent
Exclusion Criteria
* Contra-indications for MR scanning, including patients with a pacemaker, cochlear implant or neurostimulator; patients with non-MR compatible metallic implants in their eye, spine, thorax or abdomen; or an aneurysm clip in their brain; patients with severe claustrophobia.
* Renal failure (GFR \< 30 ml/min) hampering safe administration of Gadolinium containing MR contrast agent.
* For the reproducibility part of the protocol: surgery, radiation and/or chemotherapy foreseen within the timeframe needed for MRI scanning.
18 Years
ALL
No
Sponsors
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Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
OTHER
Responsible Party
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H.W.M. van Laarhoven
M.D., Ph.D.
Principal Investigators
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H WM van Laarhoven, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Locations
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Academic Medical Center
Amsterdam, , Netherlands
Countries
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Other Identifiers
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NL40501.018.12
Identifier Type: -
Identifier Source: org_study_id
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