Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:35 PM
Ignite Modification Date:
2025-12-24 @ 11:35 PM
NCT ID:
NCT01674556
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.
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT01674556
Study Brief:
Protocol Section:
NCT01674556