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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)

Tracking Information
First Submitted Date  ICMJE November 21, 2013
First Posted Date  ICMJE November 26, 2013
Last Update Posted Date March 20, 2017
Actual Study Start Date  ICMJE April 2013
Actual Primary Completion Date February 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 2, 2013)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: November 21, 2013)
Reproducibility of DCE, T2* and DWI MRI in pancreatic cancer. [ Time Frame: Within 1 week ]
To assess reproducibility patients will undergo the MR measurement protocol twice within one week before start of any treatment.
Change History Complete list of historical versions of study NCT01995240 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 21, 2013)
  • 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).
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Functional Magnetic Resonance Imaging of Pancreatic Cancer: a Feasibility and Reproducibility Study
Official Title  ICMJE Functional Magnetic Resonance Imaging of Pancreatic Cancer: a Feasibility and Reproducibility Study
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Pancreatic Cancer
Intervention  ICMJE Drug: Gadobutrol
0.1 ml/kg Gadovist is administered at 5 ml/s followed by a 15 ml saline flush
Other Name: Gadovist
Study Arms  ICMJE
  • Experimental: Optimization
    For optimization of the protocol patients will undergo one DCE-MRI (Gadobutrol), T2* MRI and DWI MRI scan.
    Intervention: Drug: Gadobutrol
  • Experimental: Reproducibility
    For determination of the reproducibility patients will undergo two DCE-MRI (Gadobutrol), T2* MRI and DWI MRI scans within one week.
    Intervention: Drug: Gadobutrol
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 24, 2017)
23
Original Estimated Enrollment  ICMJE
 (submitted: November 21, 2013)
30
Actual Study Completion Date  ICMJE February 2017
Actual Primary Completion Date February 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01995240
Other Study ID Numbers  ICMJE NL40501.018.12
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party H.W.M. van Laarhoven, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Study Sponsor  ICMJE Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: H WM van Laarhoven, M.D., Ph.D. Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
PRS Account Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Verification Date March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP