NCT02907073

Positron Emission Tomography (PET) Imaging Studies With NIS Reporter

First In-human PET Imaging Studies With NIS Reporter [18F]BF4

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Accepted

Summary

The goal of this proposal is to perform first-in-man evaluation of and experimental imaging agent F-18 tetrafluoroborate (BF4) or (TFB).

Detailed description

F-18 tetrafluoroborate (BF4) or (TFB) is being used as a PET (Positron Emission Tomography) 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 I-123 or Tc-99m SPECT for monitoring hNIS transduction effected by viral therapies. The proposed work is designed to 1) evaluate its safety, biodistribution, metabolism and radiation dosimetry characteristics in 8 healthy human volunteers and 2) evaluate the imaging feasibility in comparison with I-123 or 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.

Conditions

• Myeloma
• Endometrial Cancer

Interventions

Type	Name	Description
DRUG	BF4	Single IV dose of 9-11 millicurie (mCi) sodium \[Fluorine-18\] radiolabeled B4\^F

Timeline

• Start date: 2016-09-01
• Primary completion: 2017-12-01
• Completion: 2017-12-01
• First posted: 2016-09-20
• Last updated: 2019-05-17
• Results posted: 2019-05-17

Locations

1 site across 1 country: United States