Ultrasound-assisted Treatment of Inoperable Pancreatic Cancer

September 23, 2015 updated by: Haukeland University Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Phase 1

Contacts and Locations

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

Study Locations

  • Norway
      • Bergen,, Norway
        • Haukeland University Hospital

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.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Study Plan

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

How is the study designed?

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Toxic effects and safety of gemcitabine in combination with US contrast agent under sonication with gemcitabine alone.
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.
Two years

Secondary Outcome Measures

Outcome Measure
Time Frame
tumor size
Time Frame: one year
one year

Other Outcome Measures

Outcome Measure
Time Frame
tumor size
Time Frame: one year
one year

Collaborators and Investigators

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

Sponsor

Haukeland University Hospital

Investigators

  • Principal Investigator: Georg Dimcevski, Haukeland University Hospital

Publications and helpful links

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

General Publications

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 Major Dates

Study Start

February 1, 2012

Primary Completion (ACTUAL)

January 1, 2015

Study Completion (ACTUAL)

January 1, 2015

Study Registration Dates

First Submitted

July 13, 2012

First Submitted That Met QC Criteria

August 27, 2012

First Posted (ESTIMATE)

August 29, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

September 24, 2015

Last Update Submitted That Met QC Criteria

September 23, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2011/1601

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe