Ultrasound-assisted Treatment of Inoperable Pancreatic Cancer

NCT ID: NCT01674556

Last Updated: 2015-09-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-02-29
• Study Completion Date: 2015-01-31

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.

Conditions

Pancreatic Adenocarcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Contrast-enhanced ultrasound (CEUS)

Group Type: EXPERIMENTAL

Gemzar

Intervention Type: DRUG

Gemcitabine in combination with ultrasound (US) contrast agent under sonication

Interventions

Gemzar

Gemcitabine in combination with ultrasound (US) contrast agent under sonication

Intervention Type: DRUG

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Haukeland University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Georg Dimcevski

Role: PRINCIPAL_INVESTIGATOR

Haukeland University Hospital

Locations

Haukeland University Hospital

Bergen, , Norway

Countries

Norway

References

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.

Reference Type: DERIVED

PMID: 27744037 (View on PubMed)

Other Identifiers

2011/1601

Identifier Type: -

Identifier Source: org_study_id