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Clinical Trial Summary

The goal of this proposal is to perform first-in-man evaluation of the imaging probe F-18 tetrafluoroborate (BF4) as a PET imaging biomarker for expression of the human sodium/iodide symporter (hNIS) in tissues. .


Clinical Trial Description

The goal of this proposal is to perform first-in-man evaluation of the imaging probe F-18 tetrafluoroborate (BF4) as a PET imaging biomarker for expression of the human sodium/iodide symporter (hNIS) in tissues. Imaging of functional hNIS activity in tissues with [18F]BF4 is anticipated to provide superior sensitivity and image quality to Tc-99m SPECT for monitoring hNIS transduction effected by viral therapies. The proposed work is designed to 1) evaluate the imaging feasibility in comparison with Tc-99m SPECT of hNIS expression in a) 10 myeloma patients treated with Edmonston Measles virus-NIS (MV-NIS) and b) 10 endometrial cancer patients treated with vesicular stomatitis virus engineered to express human interferon-and NIS (VSV-hINF-NIS). This data will be necessary to support future regulatory submissions. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03456908
Study type Interventional
Source Mayo Clinic
Contact
Status Completed
Phase Phase 1
Start date March 16, 2018
Completion date December 31, 2019