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Functional Magnetic Resonance Imaging of Pancreatic Cancer: a Feasibility and Reproducibility Study (REMP)

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ClinicalTrials.gov Identifier: NCT01995240
Recruitment Status : Completed
First Posted : November 26, 2013
Last Update Posted : March 20, 2017
Sponsor:
Information provided by (Responsible Party):
H.W.M. van Laarhoven, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Drug: Gadobutrol Not Applicable

Detailed Description:

Background of the study:

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Functional Magnetic Resonance Imaging of Pancreatic Cancer: a Feasibility and Reproducibility Study
Actual Study Start Date : April 2013
Actual Primary Completion Date : February 2017
Actual Study Completion Date : February 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Gadobutrol

Arm Intervention/treatment
Experimental: Optimization
For optimization of the protocol patients will undergo one DCE-MRI (Gadobutrol), T2* MRI and DWI MRI scan.
Drug: Gadobutrol
0.1 ml/kg Gadovist is administered at 5 ml/s followed by a 15 ml saline flush
Other Name: Gadovist

Experimental: Reproducibility
For determination of the reproducibility patients will undergo two DCE-MRI (Gadobutrol), T2* MRI and DWI MRI scans within one week.
Drug: Gadobutrol
0.1 ml/kg Gadovist is administered at 5 ml/s followed by a 15 ml saline flush
Other Name: Gadovist




Primary Outcome Measures :
  1. Reproducibility of DCE, T2* and DWI MRI in pancreatic cancer. [ Time Frame: Within 1 week ]

    To assess reproducibility, 15 patients will undergo the MR measurement protocol twice within one week before start of any treatment.

    Reproducibility of; DWI: mean ADC of the whole tumor. DCE: mean Ktrans of the whole tumor. T2*: average value of the whole tumor.



Secondary Outcome Measures :
  1. Compare in vivo measurements of tumor vascularity, hypoxia and stroma using DCE-MRI, T2* MRI and DWI with immunohistochemically determined markers of vascularity, hypoxia and stroma in pancreatic tumor tissue [ Time Frame: Within 1 week ]
    In those patients for whom tumor tissue is available which has not been treated with radiation or chemotherapy, DCE-MRI, T2* MRI and DWI will be compared with immunohistochemical markers of vascularity, hypoxia and stroma (e.g. CD-31, HIF1-alfa, CA9, GLUT1, PAI-1, VEGF, anti-SMA).

  2. To explore the relation between in vivo measurements of tumor vascularity, hypoxia and stroma using DCE-MRI, T2* MRI and DWI and treatment outcome. [ Time Frame: 1 year ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with pancreatic tumors, with histological or cytological proof of adenocarcinoma or a high suspicion on CT imaging.
  • Any tumor with a size ≥ 1cm
  • WHO-performance score 0-2
  • Written informed consent

Exclusion Criteria:

  • Any psychological, familial, sociological or geographical condition potentially hampering adequate informed consent or compliance with the study protocol.
  • 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.

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): NCT01995240


Locations
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Netherlands
Academic Medical Center
Amsterdam, Netherlands, 1105AZ
Sponsors and Collaborators
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Investigators
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Principal Investigator: H WM van Laarhoven, M.D., Ph.D. Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

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Responsible Party: H.W.M. van Laarhoven, M.D., Ph.D., Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
ClinicalTrials.gov Identifier: NCT01995240     History of Changes
Other Study ID Numbers: NL40501.018.12
First Posted: November 26, 2013    Key Record Dates
Last Update Posted: March 20, 2017
Last Verified: March 2017
Keywords provided by H.W.M. van Laarhoven, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA):
pancreatic cancer
MRI
reproducibility
optimalization
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases