Ignite Creation Date:
2025-12-24 @ 11:35 PM
Ignite Modification Date:
2025-12-25 @ 9:25 PM
Study NCT ID:
NCT01674556
Status:
COMPLETED
Last Update Posted:
2015-09-24
First Post:
2012-07-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Ultrasound-assisted Treatment of Inoperable Pancreatic Cancer
Sponsor:
Haukeland University Hospital
Organization:
Study Overview
Official Title:
Treatment of Pancreatic Adenocarcinoma by Combining Contrast Agent and Gemitabine Under Sonification
Status:
COMPLETED
Status Verified Date:
2015-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Detailed Description:
The primary outcome is monitor for toxicity effect for the combination therapy.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: