Back to resultsUltrasound-assisted Treatment of Inoperable Pancreatic Cancer
Primary Purpose
Pancreatic Adenocarcinoma
Status
Completed
Phase
Phase 1
Locations
Norway
Study Type
Interventional
Intervention
Gemzar
Sponsored by
About this trial
This is an interventional treatment trial for Pancreatic Adenocarcinoma focused on measuring pancreatic, cancer, adenocarcinoma, Ultrasound, CEUS
Eligibility Criteria
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.
Sites / Locations
- Haukeland University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Contrast-enhanced ultrasound (CEUS)
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
tumor size
Full Information
NCT ID
NCT01674556
First Posted
July 13, 2012
Last Updated
September 23, 2015
Sponsor
Haukeland University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01674556
Brief Title
Ultrasound-assisted Treatment of Inoperable Pancreatic Cancer
Official Title
Treatment of Pancreatic Adenocarcinoma by Combining Contrast Agent and Gemitabine Under Sonification
Study Type
Interventional
2. Study Status
Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
February 2012 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
January 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Haukeland University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
The primary outcome is monitor for toxicity effect for the combination therapy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Adenocarcinoma
Keywords
pancreatic, cancer, adenocarcinoma, Ultrasound, CEUS
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Contrast-enhanced ultrasound (CEUS)
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Gemzar
Intervention Description
Gemcitabine in combination with ultrasound (US) contrast agent under sonication
Primary Outcome Measure Information:
Title
Toxic effects and safety of gemcitabine in combination with US contrast agent under sonication with gemcitabine alone.
Description
To evaluate and compare the toxic effects and safety of gemcitabine in combination with US contrast agent under sonication with gemcitabine alone.
Time Frame
Two years
Secondary Outcome Measure Information:
Title
tumor size
Time Frame
one year
Other Pre-specified Outcome Measures:
Title
tumor size
Time Frame
one year
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Georg Dimcevski
Organizational Affiliation
Haukeland University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Haukeland University Hospital
City
Bergen,
Country
Norway
12. IPD Sharing Statement
Citations:
PubMed Identifier
27744037
Citation
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.
Results Reference
derived
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Ultrasound-assisted Treatment of Inoperable Pancreatic Cancer
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