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


Phase 1
N/A
N/A
Open (Enrolling)
Both
Pancreatic Adenocarcinoma

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Trial Information

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


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


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Toxic effects and safety of gemcitabine in combination with US contrast agent under sonication with gemcitabine alone.

Outcome Description:

To evaluate and compare the toxic effects and safety of gemcitabine in combination with US contrast agent under sonication with gemcitabine alone.

Outcome Time Frame:

Two years

Safety Issue:

Yes

Principal Investigator

Georg Dimcevski

Investigator Role:

Principal Investigator

Investigator Affiliation:

Haukeland University Hospital

Authority:

Norway: Ethics Committee

Study ID:

2011/1601

NCT ID:

NCT01674556

Start Date:

February 2012

Completion Date:

December 2014

Related Keywords:

  • Pancreatic Adenocarcinoma
  • pancreatic
  • cancer
  • adenocarcinoma
  • Ultrasound
  • CEUS
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous

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