<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01674556</url>
  </required_header>
  <id_info>
    <org_study_id>2011/1601</org_study_id>
    <nct_id>NCT01674556</nct_id>
  </id_info>
  <brief_title>Ultrasound-assisted Treatment of Inoperable Pancreatic Cancer</brief_title>
  <official_title>Treatment of Pancreatic Adenocarcinoma by Combining Contrast Agent and Gemitabine Under Sonification</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Haukeland University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Haukeland University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators primary aim is to increase chemotherapeutic drug uptake in inoperable&#xD;
      tumours&#xD;
&#xD;
      The specific sub-objectives of the studies are:&#xD;
&#xD;
        -  To quantify tumour sizes and relate it to the patient survival over time, dependent of&#xD;
           treatment method.&#xD;
&#xD;
        -  To evaluate and compare the toxic effects and safety of gemcitabine in combination with&#xD;
           US contrast agent under sonication with gemcitabine alone.&#xD;
&#xD;
        -  Develop and validate new ultrasound perfusion algorithms based on burst- replenishment&#xD;
           for diagnosis and monitoring of therapy.&#xD;
&#xD;
        -  To quantify gemcitabine and its main metabolites in plasma and in circulating&#xD;
           mononuclear cells before, during and after pancreatic sonication, and to quantify the&#xD;
           concentration of intracellular endogenous nucleotides in circulating mononuclear cells&#xD;
           at the same time points.&#xD;
&#xD;
        -  To assess plasma and tissue concentrations of gemcitabine, its main metabolites and&#xD;
           endogenous nucleotides in those patients where surgical resection can be performed on&#xD;
           standard clinical indications.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The primary outcome is monitor for toxicity effect for the combination therapy.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>February 2012</start_date>
  <completion_date type="Actual">January 2015</completion_date>
  <primary_completion_date type="Actual">January 2015</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Toxic effects and safety of gemcitabine in combination with US contrast agent under sonication with gemcitabine alone.</measure>
    <time_frame>Two years</time_frame>
    <description>To evaluate and compare the toxic effects and safety of gemcitabine in combination with US contrast agent under sonication with gemcitabine alone.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>tumor size</measure>
    <time_frame>one year</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>tumor size</measure>
    <time_frame>one year</time_frame>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">25</enrollment>
  <condition>Pancreatic Adenocarcinoma</condition>
  <arm_group>
    <arm_group_label>Contrast-enhanced ultrasound (CEUS)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Gemzar</intervention_name>
    <description>Gemcitabine in combination with ultrasound (US) contrast agent under sonication</description>
    <arm_group_label>Contrast-enhanced ultrasound (CEUS)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with inoperable pancreatic cancer (ICD-10 C25.0-3) at the Department of&#xD;
             Surgical Gastroenterology of Haukeland University Hospital, who have volunteered to&#xD;
             participate&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient participated in an investigational study within 30 days prior to study entry&#xD;
             (or, if longer, within five half-lives of the last dose of any investigational drug).&#xD;
&#xD;
          -  Patient has severe chronic obstructive pulmonary disease or severe chronic asthma.&#xD;
&#xD;
          -  Patient has a history of cardiovascular ischemia, acute myocardial infarction or&#xD;
             unstable angina within 3 months prior to study entry.&#xD;
&#xD;
          -  Patient has a history of any psychiatric disorder or cognitive impairment that would&#xD;
             interfere with participation in the study.&#xD;
&#xD;
          -  Patient has a known history of Hepatitis B, Hepatitis C or HIV infection.&#xD;
&#xD;
          -  Patient requires dialysis or has severely impaired renal function, defined as a serum&#xD;
             creatinine &gt; 180 mmol/L at the Screening Visit.&#xD;
&#xD;
          -  Patient has severe impairment of liver function, defined as a serum albumin level ≤ 25&#xD;
             g/L and/or a Protrombin Time INR &gt; 2.3 (or APTT &gt; 6 seconds above the upper limit of&#xD;
             normal) at the Screening Visit.&#xD;
&#xD;
          -  Patient is pregnant or is breast-feeding.&#xD;
&#xD;
          -  Patient is allergic to or intolerant of gemcitabine&#xD;
&#xD;
          -  Patient is allergic to or intolerant of SonoVue® BRACCO ultrasound contrast agent&#xD;
&#xD;
          -  Any reason why, in the opinion of the investigator, the patient should not&#xD;
             participate.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Georg Dimcevski</last_name>
    <role>Principal Investigator</role>
    <affiliation>Haukeland University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Haukeland University Hospital</name>
      <address>
        <city>Bergen,</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Norway</country>
  </location_countries>
  <verification_date>September 2015</verification_date>
  <study_first_submitted>July 13, 2012</study_first_submitted>
  <study_first_submitted_qc>August 27, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 29, 2012</study_first_posted>
  <last_update_submitted>September 23, 2015</last_update_submitted>
  <last_update_submitted_qc>September 23, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 24, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>pancreatic</keyword>
  <keyword>cancer</keyword>
  <keyword>adenocarcinoma</keyword>
  <keyword>Ultrasound</keyword>
  <keyword>CEUS</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Adenocarcinoma</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Gemcitabine</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01674556
org study id: 2011/1601
nct id: NCT01674556
lead sponsor: 
has dmc: No
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.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Toxic effects and safety of gemcitabine in combination with US contrast agent under sonication with gemcitabine alone.
time frame: Two years
description: To evaluate and compare the toxic effects and safety of gemcitabine in combination with US contrast agent under sonication with gemcitabine alone.
measure: tumor size
time frame: one year
measure: tumor size
time frame: one year
arm group label: Contrast-enhanced ultrasound (CEUS)
arm group type: Experimental
intervention type: Drug
intervention name: Gemzar
description: Gemcitabine in combination with ultrasound (US) contrast agent under sonication
arm group label: Contrast-enhanced ultrasound (CEUS)
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Georg Dimcevski
role: Principal Investigator
affiliation: Haukeland University Hospital
facility: 
country: Norway
responsible party type: Sponsor
mesh term: Adenocarcinoma
mesh term: Gemcitabine