FLUOPANC-trial - Intraoperative near-infrared fluorescence imaging in pancreatic- and extrahepatic bile duct tumors using cRGD-ZW800-1 and dedicated imaging systems: A phase II feasibility, dose-ranging and optimal dose-(interval) selection trial

Phase 2

Recruiting

Conditions: 10017991
pancreatic/bile duct cancer
pancreatic/cholangio carcinoma
10017990

Registration Number: NL-OMON54735

Lead Sponsor: eids Universitair Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 20

Inclusion Criteria

- Patients >18 years old;
- Patients scheduled and eligible for open/robotic resection because of
(histologically proven) pancreatic carcinoma with or without neoadjuvant
treatment. As well as patients scheduled and eligible for resection because of
(histologically proven) distal or perihilar cholangiocarcinoma with or without
neoadjuvant treatment.
- All women of childbearing potential and all males must practice effective
contraception during the study and be willing and able to continue
contraception for at least 30 days after their last dose of study treatment.
- Patients should be capable and willing to give informed consent before study
specific procedures;

Exclusion Criteria

- History of a clinically significant allergy or anaphylactic reactions;
- Patients with renal insufficiency (eGFR<60 ml/min/1,73 m2);
- Patients with a previous kidney transplantation in the medical history;
- Pregnant women, or women giving breast feeding;
- Patients who are immunocompromised and do not have the ability to respond
normally to an infection due to an impaired or weakened immune system, caused
by either a pre-existing disease or concomitant medications (excluding intended
neoadjuvant treatment);
- Presence of any psychological, familial, sociological or geographical
condition potentially hampering compliance with the study protocol and
follow-up schedule; those conditions should be discussed with the patient
before registration in the trial;
- Any condition that the investigator considers to be potentially jeopardizing
the patients well-being or the study objectives.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Visualization of the primary tumor using cRGD-ZW800-1 and dedicated<br /><br>NIR-Fluorescence imaging system. Visualization is measured using the<br /><br>tumor-to-background ratio (TBR) in in-vivo and ex-vivo setting. A<br /><br>tumor-to-background ratio (TBR) of at least >=1.5 provides sufficient contrast<br /><br>for adequate visualization/delineation and will therefore be used as cut-off<br /><br>value. </p><br>

Secondary Outcome Measures