Haukeland University Hospital
Bergen, Norway
NCT Number: NCT01674556
The investigators primary aim is to increase chemotherapeutic drug uptake in inoperable tumours
The specific sub-objectives of the studies are:
* To quantify tumour sizes and relate it to the patient survival over time, dependent of treatment method. * To evaluate and compare the toxic effects and safety of gemcitabine in combination with US contrast agent under sonication with gemcitabine alone. * Develop and validate new ultrasound perfusion algorithms based on burst- replenishment for diagnosis and monitoring of therapy. * To quantify gemcitabine and its main metabolites in plasma and in circulating mononuclear cells before, during and after pancreatic sonication, and to quantify the concentration of intracellular endogenous nucleotides in circulating mononuclear cells at the same time points. * To assess plasma and tissue concentrations of gemcitabine, its main metabolites and endogenous nucleotides in those patients where surgical resection can be performed on standard clinical indications.
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Interventional
Phase 1
Bergen, Norway
The primary outcome is monitor for toxicity effect for the combination therapy.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Gemcitabine in combination with ultrasound (US) contrast agent under sonication
Time frame: Two years
To evaluate and compare the toxic effects and safety of gemcitabine in combination with US contrast agent under sonication with gemcitabine alone.
Time frame: one year
Time frame: one year
Haukeland University Hospital
Other
Treatment of Pancreatic Adenocarcinoma by Combining Contrast Agent and Gemitabine Under Sonification
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