Ultrasound-assisted Treatment of Inoperable Pancreatic Cancer

NCT01674556 | Completed Phase 1

• 1 other identifier: 2011/1601
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatic Adenocarcinoma

Keywords

pancreatic; cancer; adenocarcinoma; Ultrasound; CEUS

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• tumor size

  one year

Other Outcomes (1)

• tumor size

  one year

Study Arms (1)

Contrast-enhanced ultrasound (CEUS)

EXPERIMENTAL

Drug: Gemzar

Interventions

Gemzar DRUG

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

Contrast-enhanced ultrasound (CEUS)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Haukeland University Hospital: lead

Study Sites (1)

Haukeland University Hospital

Bergen, Norway

Location

Related Publications (1)

• 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.

  PMID: 27744037 DERIVED

MeSH Terms

Conditions

Neoplasms; Adenocarcinoma

Interventions

Gemcitabine

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Georg Dimcevski

  Haukeland University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2012
• First Posted: August 29, 2012
• Study Start: February 1, 2012
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: September 24, 2015

Record last verified: 2015-09

Locations

NO (1)