Pancreatic Cancer
Conditions
Keywords
pancreatic cancer, MRI, reproducibility, optimalization
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.
Interventions
DRUGGadobutrol
0.1 ml/kg Gadovist is administered at 5 ml/s followed by a 15 ml saline flush
Sponsors
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reproducibility of DCE, T2* and DWI MRI in pancreatic cancer. | 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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. | 1 year | — |
Countries
Netherlands
Outcome results
None listed