©2024 Stanford Medicine
Cetuximab-IRDye 800CW and Intraoperative Imaging in Finding Pancreatic Cancer in Patients Undergoing Surgery
Not Recruiting
Trial ID: NCT02736578
Purpose
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.
Official Title
Intraoperative Pancreatic Cancer Detection Using Multimodality Molecular Imaging
Stanford Investigator(s)
George A. Poultsides, MD, MS
Professor of Surgery (General Surgery)
Eligibility
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
Intervention(s):
drug: Cetuximab-IRDye800
drug: Cetuximab
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
CCTO
650-498-7061