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 @ 7:35 PM
Ignite Modification Date:
2025-12-24 @ 7:35 PM
NCT ID:
NCT02791503
Eligibility Criteria:
Inclusion Criteria:
* Radiologic confirmation of LAPC by at least ceCT of chest and abdomen (with the upper abdomen scanned according to a dedicated 3mm slice multiphase pancreatic tumor protocol);
* Maximum tumor diameter ≤ 5 cm;
* Histological or cytological confirmation of pancreatic adenocarcinoma;
* Age \> 18 years;
* ASA-classification 0 - 3; World Health Organisation scale (WHO) performance status 0 - 1 ;
* Adequate bile drainage in case of biliary obstruction;
* Written informed consent;
Exclusion Criteria:
* Resectable pancreatic adenocarcinoma as discussed by our multidisciplinary hepatobiliary team;
* The presence of suspect lymph nodes
* Stage IV pancreatic carcinoma;
* Trans-mucosal tumor invasion into surrounding duodenum or stomach;
* History of epilepsy;
* History of cardiac disease:
* Congestive heart failure \>NYHA class 2;
* Active Coronary Artery Disease (defined as myocardial infarction within 6 months prior to screening);
* Ventricular cardiac arrhythmias requiring anti-arrhythmic therapy or pacemaker (beta blockers for antihypertensive regimen are permitted; atrial fibrillation is not contra-indicated);
* Uncontrolled hypertension. Blood pressure must be ≤160/95 mmHg at the time of screening on a stable antihypertensive regimen;
* Compromised liver function (e.g. signs of portal hypertension, INR \> 1,5 without use of anticoagulants, ascites);
* Uncontrolled infections (\> grade 2 NCI-CTC version 3.0);
* Pregnant or breast-feeding subjects. Women of childbearing potential must have a negative pregnancy test performed within 7 days of the start of treatment;
* Immunotherapy prior to the procedure;
* Radiotherapy prior to study enrollment;
* Previous surgical therapy for pancreatic cancer;
* Second primary malignancy, except adequately treated non-melanoma skin cancer, in situ carcinoma of the cervis uteri or other malignancies treated at least 5 years previously without signs of recurrence;
* Allergic to contrast agent.
* Any implanted stimulation device;
* Any condition that is unstable or that could jeopardize the safety of the subject and their compliance in the study;
* Non-removable Self Expanding Metal biliary Stent (SEMS), which cannot be removed during surgery.
* Contra-indications for MRI since no safety data for 0.35 Tesla MRI scanners are available on electronic devices such as pacemakers or implanted defibrillators, deep brain stimulators, cochlear implants, this constitutes an absolute contraindication for this study, even for devices that have been considered safe for MRI scans with higher field strengths.
* Patients who have a metallic foreign body in their eye, or who have an aneurysm clip in their brain, cannot have an MRI scan since the magnetic field may dislodge the metal
* Patients with severe claustrophobia may not be able to tolerate an MRI scan
* Patients with a hip prosthesis will not be eligible for the MRI scan
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
100 Years
Study:
NCT02791503
Study Brief:
Protocol Section:
NCT02791503