Clinical trial NCT01995240: Functional Magnetic Resonance Imaging of Pancreatic Cancer: a Feasibility and Reproducibility Study
Official title: Functional Magnetic Resonance Imaging of Pancreatic Cancer: a Feasibility and Reproducibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pancreatic Cancer
Keywords: pancreatic cancer
MRI
reproducibility
optimalization
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
First posted: 2013-11-26
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Eligibility 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.

Primary outcomes:
measure: Reproducibility of DCE, T2* and DWI MRI in pancreatic cancer.
timeFrame: Within 1 week
Secondary outcomes:
measure: 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
timeFrame: Within 1 week
measure: To explore the relation between in vivo measurements of tumor vascularity, hypoxia and stroma using DCE-MRI, T2* MRI and DWI and treatment outcome.
timeFrame: 1 year
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Academic Medical Center
Study officials:
affiliation: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
name: H WM van Laarhoven, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: