Pancreatic cancer (pancreatic carcinoma) Extrahepatic bile duct cancer (cholangiocarcinoma)
Conditions
Interventions
Product Name: cRGD-ZW800-1
Product Code: cRGD-ZW800-1
Pharmaceutical Form: Solution for injection
INN or Proposed INN: cRGD-ZW800-1
Other descriptive name: RPR109881
Concentration unit: mg milligram(s
Sponsors
Leiden University Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
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; Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 10 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: - To assess the feasibility, safety and tolerability of cRGD-ZW800-1 for visualization of (neoadjuvantly treated) pancreatic carcinomas, perihilar or distal cholangiocarcinomas and if present associated metastatic lymph nodes and their distant metastases using dedicated NIR fluorescence imaging systems. ;Secondary Objective: - To define the optimal dose and dose interval of a single intravenous bolus injection of cRGD-ZW800-1.;Primary end point(s): Visualization of the primary tumor using cRGD-ZW800-1 and dedicated NIR-Fluorescence imaging system. Visualization is measured using the tumor-to-background ratio (TBR) in in-vivo and ex-vivo setting. A tumor-to-background ratio (TBR) of at least =1.5 provides sufficient contrast for adequate visualization/delineation and will therefore be used as cut-off value. ;Timepoint(s) of evaluation of this end point: Peri-operatively in-vivo/ex-vivo, post-operatively ex-vivo | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Number and grade of treatment-emergent (serious) adverse events ((S)AEs). - Concordance between clinical assessment, histopathologic examination and NIR-Fluorescence imaging assessment of the resected tumor, lymph nodes and/or metastatic lesions and their histopathologic result. - Define the optimal dose and dose interval of a single intravenous bolus injection of cRGD-ZW800-1. The optimal dose and ideal time window between administration of the study drug and intra-operative imaging during surgery will be assessed after all consecutive patients have been included, the endpoint for the combination of optimal dose and dose-interval is a tumor-to-background ratio of at least =1.5. - Tumor positive margins detected with NIR fluorescence imaging using cRGD-ZW800-1, referenced to histopathology. - Number of tumor-positive lymph nodes and metastases detected by NIR fluorescence imaging using cRGD-ZW800-1, referenced to histopathology.;Timepoint(s) of evaluation of this end point: Peri-operatively, post-operatively and at follow-up | — |
Countries
Netherlands
Contacts
Public ContactA.L. Vahrmeijer
Leiden University Medical Center
Outcome results
None listed