pancreatic/bile duct cancer pancreatic/cholangio carcinoma
Conditions
Interventions
Intervention: Single bolus injection of cRGD-ZW800-1 2-24h before surgery.
Intra-operative in-vivo assessment of NIR-fluorescence of tumor, lymph nodes,
possible distant metastasis and anatomical re
Sponsors
Leids Universitair Medisch Centrum
Eligibility
Age
18 Years to 99 Years
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;
Exclusion criteria
Exclusion criteria: - History of a clinically significant allergy or anaphylactic reactions; - Patients with renal insufficiency (eGFR
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| - 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. | — |
Countries
Netherlands
Outcome results
None listed