Ultrasound-assisted Treatment Of Inoperable Pancreatic Cancer

Study Overview

Ultrasound-assisted Treatment of Inoperable Pancreatic Cancer

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

Pancreatic Adenocarcinoma

DRUG: Gemzar

2011/1601

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2012-07-13	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2015-09-23
First Submitted that Met QC Criteria 2012-08-27	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2015-09-24
First Posted (ESTIMATED) 2012-08-29	Results First Posted N/A	Last Verified 2015-09

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Contrast-enhanced ultrasound (CEUS)	DRUG: Gemzar Gemcitabine in combination with ultrasound (US) contrast agent under sonication

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: Contrast-enhanced ultrasound (CEUS)

DRUG: Gemzar

Gemcitabine in combination with ultrasound (US) contrast agent under sonication

Primary Outcome Measures	Measure Description	Time Frame
Toxic effects and safety of gemcitabine in combination with US contrast agent under sonication with gemcitabine alone.	To evaluate and compare the toxic effects and safety of gemcitabine in combination with US contrast agent under sonication with gemcitabine alone.	Two years

Secondary Outcome Measures	Measure Description	Time Frame
tumor size		one year

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:

Accepts Healthy Volunteers:

Patients with inoperable pancreatic cancer (ICD-10 C25.0-3) at the Department of Surgical Gastroenterology of Haukeland University Hospital, who have volunteered to participate

Patient participated in an investigational study within 30 days prior to study entry (or, if longer, within five half-lives of the last dose of any investigational drug).
Patient has severe chronic obstructive pulmonary disease or severe chronic asthma.
Patient has a history of cardiovascular ischemia, acute myocardial infarction or unstable angina within 3 months prior to study entry.
Patient has a history of any psychiatric disorder or cognitive impairment that would interfere with participation in the study.
Patient has a known history of Hepatitis B, Hepatitis C or HIV infection.
Patient requires dialysis or has severely impaired renal function, defined as a serum creatinine > 180 mmol/L at the Screening Visit.
Patient has severe impairment of liver function, defined as a serum albumin level ≤ 25 g/L and/or a Protrombin Time INR > 2.3 (or APTT > 6 seconds above the upper limit of normal) at the Screening Visit.
Patient is pregnant or is breast-feeding.
Patient is allergic to or intolerant of gemcitabine
Patient is allergic to or intolerant of SonoVue® BRACCO ultrasound contrast agent
Any reason why, in the opinion of the investigator, the patient should not participate.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

PRINCIPAL_INVESTIGATOR: Georg Dimcevski, Haukeland University Hospital

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Dimcevski G, Kotopoulis S, Bjanes T, Hoem D, Schjott J, Gjertsen BT, Biermann M, Molven A, Sorbye H, McCormack E, Postema M, Gilja OH. A human clinical trial using ultrasound and microbubbles to enhance gemcitabine treatment of inoperable pancreatic cancer. J Control Release. 2016 Dec 10;243:172-181. doi: 10.1016/j.jconrel.2016.10.007. Epub 2016 Oct 12.

Learn

Resources

PatientS

Caregivers

Clinical Trial Record