Clinical trial · Interventional
Panitumumab-IRDye800 in Patients With Pancreatic Cancer Undergoing Surgery
A Phase I/II Study Evaluating the Safety and Pharmacokinetics of Panitumumab-IRDye800 as an Optical Imaging Agent to Detect Pancreas Cancer During Surgical Procedures
NCT03384238CI-TRIAL-00105689recruitingPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This phase I/II trial studies the side effects and best dose of panitumumab-IRDye800 and to see how well it works in finding cancer in patients with pancreatic cancer who are undergoing surgery. Panitumumab-IRDye800 is a combination of the antibody drug panitumumab and IRDye800CW, an investigational dye that can be seen using a special camera. Panitumumab-IRDye800 may attach to tumor cells and make them more visible during surgery in patients with pancreatic cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreatic Adenocarcinoma | Pancreatic Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Fluorescence Imaging | Procedure | — | UNRESOLVED |
| Panitumumab | Biological | Panitumumab | ALIAS |
| Panitumumab-IRDye800 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (5)
- type
- EXPERIMENTAL
- label
- Cohort 1a
- description
- A test/loading dose of 100 mg of unlabeled Panitumumab (fixed dose) will be administered via a 60 minute IV infusion prior to infusion of the Panitumumab IRDye800. Cohort 1a will receive 25 mg of Panitumumab IRDye800 with a 100 mg unlabeled test/loading dose of Panitumumab. The surgical resection will then occur 2 to 5 days after infusion. Intraoperative imaging will be performed using the intraoperative optical imaging devices
- interventionNames
- Procedure: Fluorescence Imaging
- Biological: Panitumumab
- Drug: Panitumumab-IRDye800
- type
- EXPERIMENTAL
- label
- Cohort 1b
- description
- Cohort 1b will receive 50 mg of Panitumumab IRDye800 with a 100 mg unlabeled test/loading dose of Panitumumab. A test/loading dose of 100 mg of unlabeled Panitumumab (fixed dose) will be administered via a 60 minute IV infusion prior to infusion of the Panitumumab IRDye800. The surgical resection will then occur 2 to 5 days after infusion. Intraoperative imaging will be performed using the intraoperative optical imaging devices
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
Show eligibility criteria text
Inclusion Criteria: * Clinically suspected or biopsy-confirmed diagnosis of pancreatic adenocarcinoma * Planned standard of care surgery with curative intent for pancreatic adenocarcinoma * Life expectancy of more than 12 weeks * Karnofsky performance status of at least 70% or Eastern Cooperative Oncology Group (ECOG)/Zubrod level =\< 1 * Hemoglobin \>= 9 gm/dL * Platelet count \>= 100,000/mm\^3 * Magnesium \> the lower limit of normal per institution normal lab values * Potassium \> the lower limit of normal per institution normal lab values * Calcium \> the lower limit of normal per institution normal lab values * Thyroid-stimulating hormone (TSH) \< 13 micro international units/mL Exclusion Criteria: * Received an investigational drug within 30 days prior to first dose of panitumumab-IRDye800 * Myocardial infarction (MI); cerebrovascular accident (CVA); uncontrolled congestive heart failure (CHF); or unstable angina within 6 months prior to enrollment * History of infusion reactions to panitumumab or other monoclonal antibody therapies * Pregnant or breastfeeding * Evidence of corrected QT (QTc) prolongation on pretreatment electrocardiography (ECG) (greater than 440 ms in males or greater than 460 ms in females) * Lab values that in the opinion of the physician would prevent surgical resection * Patients receiving class IA (quinidine, procainamide) or class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents
References
Publications (1)
- DERIVEDLu G, van den Berg NS, Martin BA, Nishio N, Hart ZP, van Keulen S, Fakurnejad S, Chirita SU, Raymundo RC, Yi G, Zhou Q, Fisher GA, Rosenthal EL, Poultsides GA. Tumour-specific fluorescence-guided surgery for pancreatic cancer using panitumumab-IRDye800CW: a phase 1 single-centre, open-label, single-arm, dose-escalation study. Lancet Gastroenterol Hepatol. 2020 Aug;5(8):753-764. doi: 10.1016/S2468-1253(20)30088-1. Epub 2020 May 14. PMID 32416764