Clinical trial · Interventional
Cetuximab-IRDye 800CW and Intraoperative Imaging in Finding Pancreatic Cancer in Patients Undergoing Surgery
Intraoperative Pancreatic Cancer Detection Using Multimodality Molecular Imaging
NCT02736578CI-TRIAL-00039217terminatedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Logistics
Summary
Brief summary (as posted)
This phase 1-2 trial studies the side effects and best dose of cetuximab-IRDye 800CW when used with intraoperative imaging, to determine the utility of cetuximab-IRDye 800CW to identify and assess pancreatic cancer in patients undergoing surgery to remove the tumor. Cetuximab-IRDye 800CW may help doctors better identify cancer in the operating room by making the cancer visible when viewed through a fluorescent imaging system.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cetuximab | Drug | Cetuximab | ALIAS |
| Cetuximab-IRDye800 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Cetuximab IRDye800, 50 mg
- description
- On day 0, participants receive a 100 mg cetuximab loading dose by intravenous infusion (IV), followed 1 hour later by cetuximab-IRDye 800CW IV at 50 mg, followed by surgery with intraoperative imaging within 2 to 5 days.
- interventionNames
- Drug: Cetuximab-IRDye800
- Drug: Cetuximab
- type
- EXPERIMENTAL
- label
- Cetuximab IRDye800, 100 mg
- description
- On day 0, participants receive a 100 mg cetuximab loading dose by intravenous infusion (IV), followed 1 hour later by cetuximab-IRDye 800CW IV at 100 mg, followed by surgery with intraoperative imaging within 2 to 5 days.
- interventionNames
- Drug: Cetuximab-IRDye800
- Drug: Cetuximab
Primary outcomes (1)
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 * ≥ 19 years of age * Life expectancy of more than 12 weeks * EITHER * 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 (LLN) per institution normal lab values * Potassium \> LLN * Calcium \> LLN * Thyroid-stimulating hormone (TSH) \< 13 micro International units/mL EXCLUSION CRITERIA * Received an investigational drug within 30 days prior to first dose of cetuximab 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 cetuximab or other monoclonal antibody therapies * Pregnant or breastfeeding * Evidence of QT prolongation on pretreatment electrocardiography (ECG) (greater than 440 ms in males or greater than 450 ms in females) * Lab values that in the opinion of the primary surgeon would prevent surgical resection * Patients receiving class IA (quinidine, procainamide) or class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents
References
Publications (4)
- BACKGROUNDRosenthal EL, Kulbersh BD, King T, Chaudhuri TR, Zinn KR. Use of fluorescent labeled anti-epidermal growth factor receptor antibody to image head and neck squamous cell carcinoma xenografts. Mol Cancer Ther. 2007 Apr;6(4):1230-8. doi: 10.1158/1535-7163.MCT-06-0741. PMID 17431103
- BACKGROUNDRosenthal EL, Kulbersh BD, Duncan RD, Zhang W, Magnuson JS, Carroll WR, Zinn K. In vivo detection of head and neck cancer orthotopic xenografts by immunofluorescence. Laryngoscope. 2006 Sep;116(9):1636-41. doi: 10.1097/01.mlg.0000232513.19873.da. PMID 16954995
- RESULTTummers WS, Miller SE, Teraphongphom NT, Gomez A, Steinberg I, Huland DM, Hong S, Kothapalli SR, Hasan A, Ertsey R, Bonsing BA, Vahrmeijer AL, Swijnenburg RJ, Longacre TA, Fisher GA, Gambhir SS, Poultsides GA, Rosenthal EL. Intraoperative Pancreatic Cancer Detection using Tumor-Specific Multimodality Molecular Imaging. Ann Surg Oncol. 2018 Jul;25(7):1880-1888. doi: 10.1245/s10434-018-6453-2. Epub 2018 Apr 17. PMID 29667116
- DERIVEDLwin TM, Hoffman RM, Bouvet M. The future of tumour-specific fluorescence-guided surgery for pancreatic cancer. Lancet Gastroenterol Hepatol. 2020 Aug;5(8):715-717. doi: 10.1016/S2468-1253(20)30123-0. Epub 2020 May 14. No abstract available. PMID 32416765