Clinical trial NCT01674556: Ultrasound-assisted Treatment of Inoperable Pancreatic Cancer
Official title: Treatment of Pancreatic Adenocarcinoma by Combining Contrast Agent and Gemitabine Under Sonification
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pancreatic Adenocarcinoma
Keywords: pancreatic
cancer
adenocarcinoma
Ultrasound
CEUS
Lead sponsor: Haukeland University Hospital
Sponsor class: OTHER
First posted: 2012-08-29
Enrollment: 25
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Toxic effects and safety of gemcitabine in combination with US contrast agent under sonication with gemcitabine alone.
timeFrame: Two years
Secondary outcomes:
measure: tumor size
timeFrame: one year
Other outcomes:
measure: tumor size
timeFrame: one year
Locations:
city: Bergen,
country: Norway
facility: Haukeland University Hospital
Study officials:
affiliation: Haukeland University Hospital
name: Georg Dimcevski
role: PRINCIPAL_INVESTIGATOR
References:
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.