Colorectal Cancer Clinical Trial
Official title:
Open Label Pilot Study Evaluating Diagnostic Efficacy and Dosimetry of MNPR-101-DFO*-89Zr in Patients With Solid Tumors
The goal of this study is to test a new PET imaging agent in patients with solid tumors. This tracer is made of a radioactively-labeled monoclonal antibody MNPR-101, and can show where tumors are present in the body using a PET-scan. The investigators will investigate if the new imaging agent correctly shows all tumor lesions. In the future, this method may be useful to help predict who will benefit from certain therapies. Participants will be injected with the radioactive tracer once. After injection, participants will undergo 3 PET-scans. Each PET-scan will take a maximum of 30 minutes. The PET-scans are on separate days within 10 days after injection of the tracer (e.g., 2 hours after injection plus 3-5 days and 7-10 days after injection). Furthermore, the investigators will take blood samples 6 times (5 mL each). Blood pharmacokinetics (PK) will be measured on Day 1 at 10 min, 1h, 2h, once on Days 3-5, and once on Days 7-10. The amount of radioactivity injected will range between 37-74 MBq (±10%).
This is an open-label pilot study to evaluate MNPR-101-DFO*-89Zr with Positron Emission Tomography/Computed Tomography (PET/CT) imaging in patients with solid tumor cancers: bladder/urothelial, triple-negative breast, lung, colorectal, gastric, ovarian, and pancreatic cancers. Patients will be recruited from a single center with state-of-the-art PET/CT imaging equipment. The study involves a single administration of MNPR-101-DFO*-89Zr to all participating patients. Imaging will be performed 2 hours after administration and on two additional days - once between days 3-5 and once between days 7-10. The final study visit will occur 30 days after dosing. ;
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