PET Imaging With 89Zr-DFO-Trastuzumab in Esophagogastric Cancer
The purpose of this study is to see if a new research agent named 89Zr-DFO-trastuzumab can show esophagogastric cancer tumors on a PET scan. Also to see how long 89Zr-DFO-trastuzumab lasts in the blood when given in small amounts.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||Pilot Trial of PET Imaging With 89Zr-DFO-Trastuzumab in Esophagogastric Cancer|
- Toxicity [ Time Frame: 2 years ] [ Designated as safety issue: Yes ](CTCAE v4) Incidence and nature and severity of adverse events; and change in vital signs and clinical laboratory results. Incidence and severity of adverse events will be summarized with descriptive statistics.
- feasibility [ Time Frame: 2 years ] [ Designated as safety issue: No ]Antibody imaging is considered feasible if 70% of the patients are antibody-imaging positive. Antibody imaging will be considered feasible if 7 or more of the 10 patients in the first cohort are antibody-imaging-positive.We will also require that none of these patients experience severe toxicity attributable to the initial antibody.
- metabolite analysis [ Time Frame: 2 years ] [ Designated as safety issue: No ]Samples will be obtained just prior to injection of the 89Zr DFO-trastuzumab tracer this sample will be banked at -80degree C for future testing for immune response (HAHA) if altered biodistribution is observed., and at 5 ± 2 minutes, 15 ± 5, 30 ± 9, 60 ± 19 minutes, and 120 − 240 minutes after the injection of the tracer 1, and at the time of each subsequent day of imaging.
|Study Start Date:||December 2013|
|Estimated Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
Experimental: PET Imaging With 89Zr-DFO-Trastuzumab
Patients will receive 5 mCi + 0.5 mCi of 89Zr-DFO-trastuzumab given IV over 5-10 min. Injection of cold trastuzumab will be mixed with 89Zr-DFO-trastuzumab so that total mass is equal to 50 mg . In the first ten patients we wish to obtain normal organ dosimetry, pharmacokinetics & determine optimal imaging time, therefore these patients will undergo imaging at 4 time points post injection, whole body counts & blood draws. Subsequent patients will receive the antibody & will only undergo imaging at a single time point (based on the first 10 patients) & will not have whole body counts or serial bloods for pharmacokinetics. The administration of 89Zr-DFO-trastuzumab to patients undergoing a second study will be identical as for their baseline study. Patients undergoing a second injection will only have one scan that will be performed within 1 day before or 2 days after their optimum imaging time point, determined from their baseline imaging study.
|Radiation: 89Zr-DFO-trastuzumab Device: PET imaging|
Please refer to this study by its ClinicalTrials.gov identifier: NCT02023996
|Contact: Jorge Carrasquillo, MD||212-639-2459|
|Contact: Yelena Janjigian, MD||646-888-4186|
|United States, New York|
|Memorial Sloan Kettering Cancer Center||Recruiting|
|New York, New York, United States, 10065|
|Contact: Jorge Carrasquillo, MD 212-639-2459|
|Contact: Yelena Janjigian, MD 646-888-4186|
|Principal Investigator: Jorge Carrasquillo, MD|
|Principal Investigator:||Jorge Carrasquillo, MD||Memorial Sloan-Kettering Cancer Center|