The role of the tumor microenvironment of pancreatic cancer to predict treatment outcome

Completed

Conditions: pancreatic cancer
pancreatic tumor
10017991

Registration Number: NL-OMON44790

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 95

Inclusion Criteria

* Patients with pancreatic tumors, with histological or cytological proof of adenocarcinoma or a high suspicion on CT imaging.
* Tumor size * 1cm.
* WHO-performance score 0-2.
* Scheduled for surgery or neo-adjuvant chemotherapy/radiation followed by surgery. For the reproducibility part of the study, patients who will not undergo surgery, may be included, too.
* 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 a non-MR compatible 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 MR scanning.

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>For each imaging modalities one parameter will be regarded as primary study<br /><br>endpoint. For DWI the mean ADC of the whole tumor will be taken as primary<br /><br>study endpoint. From the different parameters that can be calculated from<br /><br>DCE-MRI, following the recommendations of the Pharmacodynamic/Pharmacokinetic<br /><br>Technologies Advisory Committee, Drug Development Office, Cancer Research UK,<br /><br>we will use mean Ktrans of whole tumor as primary study endpoint. For T2* the<br /><br>average value of the whole tumor will be taken. For 18F-HX4-PET/CT mean SUV of<br /><br>the whole tumor will be used as primary study end point. For the<br /><br>immunohistochemical analyses marker expression will be assessed in terms of<br /><br>stained surface area relative to the total tumor area.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>For MRI, as mean values may average out differences and, therefore,<br /><br>underestimate differences in tumor physiology, exploratory histogram analyses<br /><br>will be performed. For 18F-HX4-PET/CT SUVmax will be determined as an<br /><br>exploratory endpoint. </p><br>