Ultrasound-assisted Treatment of Inoperable Pancreatic Cancer

Pancreatic Adenocarcinoma Clinical Trial

Official title: Treatment of Pancreatic Adenocarcinoma by Combining Contrast Agent and Gemitabine Under Sonification

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

The primary outcome is monitor for toxicity effect for the combination therapy. ;

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adenocarcinoma
• Pancreatic Adenocarcinoma

• NCT number: NCT01674556
• Study type: Interventional
• Source: Haukeland University Hospital
• Status: Completed
• Phase: Phase 1
• Start date: February 2012
• Completion date: January 2015