Ultrasound-assisted Treatment of Inoperable Pancreatic Cancer

Pancreatic Adenocarcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01674556
• Other study ID #: 2011/1601
• Status: Completed
• Phase: Phase 1
• First received: July 13, 2012
• Last updated: September 23, 2015
• Start date: February 2012
• Est. completion date: January 2015

Study information

• Verified date: September 2015
• Source: Haukeland University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adenocarcinoma
• Pancreatic Adenocarcinoma

Intervention

Drug:
• Gemzar
Gemcitabine in combination with ultrasound (US) contrast agent under sonication

Locations

Country	Name	City	State
Norway	Haukeland University Hospital	Bergen,

Sponsors (1)

Lead Sponsor	Collaborator
Haukeland University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	tumor size		one year	No
Primary	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	Yes
Secondary	tumor size		one year	No