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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Optimization | Experimental | For optimization of the protocol patients will undergo one DCE-MRI (Gadobutrol), T2* MRI and DWI MRI scan. |
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| Reproducibility | Experimental | For determination of the reproducibility patients will undergo two DCE-MRI (Gadobutrol), T2* MRI and DWI MRI scans within one week. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gadobutrol | Drug | 0.1 ml/kg Gadovist is administered at 5 ml/s followed by a 15 ml saline flush |
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| Measure | Description | Time Frame |
|---|---|---|
| Reproducibility of DCE, T2* and DWI MRI in pancreatic cancer. | 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. | Within 1 week |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| H WM van Laarhoven, M.D., Ph.D. | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Academic Medical Center | Amsterdam | 1105AZ | Netherlands |
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
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| ID | Term |
|---|---|
| C090600 | gadobutrol |
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| Within 1 week |
| 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 |
| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |