The main purpose of the study is to assess the safety of 89Zr-panitumumab as a molecular imaging agent in patients with (metastatic) pancreas cancer.
Full Title of Study: “Pilot Study of 89Zr Panitumumab in Pancreas Cancer”
- Study Type: Interventional
- Study Design
- Allocation: N/A
- Intervention Model: Single Group Assignment
- Primary Purpose: Diagnostic
- Masking: None (Open Label)
- Study Primary Completion Date: March 2022
- Drug: 89Zr-panitumumab
- Imaging Agent
Arms, Groups and Cohorts
- Experimental: 89Zr-Panitumumab
- Subjects will be injected with 1 mCi (+/- 20%) of 89Zr-panitumumab followed by PET/CT imaging 4-7 days after study drug injection.
Clinical Trial Outcome Measures
- Safety of 89Zr-panitumumab as a molecular imaging agent
- Time Frame: 7 days
- Safety is defined by the number of CTCAE v5 grade 2 or higher adverse events by Day 7 determined that are significant, definitely, probably or possibly related to 89Zr-panitumumab. Safety data will be summarized by grade, severity, and type.
Participating in This Clinical Trial
- Confirmed diagnosis of pancreatic cancer. Exclusion Criteria:
- Myocardial infarction (MI); cerebrovascular accident (CVA); uncontrolled congestive heart failure (CHF); significant liver disease; or unstable angina within 6 months prior to enrollment. – History of infusion reactions to monoclonal antibody therapies. – Pregnant or breastfeeding. – Subjects receiving Class IA (quinidine, procainamide) or Class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents. – Subjects with a history or evidence of interstitial pneumonitis or pulmonary fibrosis. – Severe renal disease or anuria. – Known hypersensitivity to deferoxamine or any of its components.
Gender Eligibility: All
Minimum Age: 19 Years
Maximum Age: N/A
Are Healthy Volunteers Accepted: No
- Lead Sponsor
- Stanford University
- Provider of Information About this Clinical Study
- Overall Official(s)
- Andrei Iagaru, Principal Investigator, Stanford Universiy
- Overall Contact(s)
- Alexander A Valencia, 650-498-5185, email@example.com
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