This is a prospective, open-label, multicenter, safety, comparative study of IV administered Tc99m-tilmanocept and unfiltered Tc99m sulfur colloid in the detection of and assessment of three dimensional tessellation localization to the liver in subjects with and without moderate to severe nonalcoholic steatohepatitis (NASH) by planar and SPECT/CT imaging. This study is designed to evaluate the safety and tolerability of Tc99m-tilmanocept in subjects with NASH.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
6
Sulfur colloid is a radiotracer that is indicated for imaging areas of functional reticuloendothelial cells in the liver, spleen, and bone marrow.
Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface.
Kettering Medical Center
Kettering, Ohio, United States
Adverse Drug Reaction
Proportion of subjects experiencing noxious pharmacologic activity/an Adverse Drug Reaction (ADR).
Time frame: 5 days after Tc 99m tilmanocept injection
Localization of Tc 99m tilmanocept
Determine the three dimensional tessellation localization of Tc 99m tilmanocept by planar and SPECT/CT imaging in subjects with NASH and asymptomatic controls.
Time frame: 5 days after Tc 99m tilmanocept injection
Localization of Tc 99m sulfur colloid
Determine the three dimensional tessellation localization of unfiltered Tc 99m sulfur colloid by planar and SPECT/CT imaging in subjects with NASH and asymptomatic controls.
Time frame: 5 days after Tc 99m tilmanocept injection
Localization Distribution Comparison
Comparison of liver localization distribution tessellation pattern intensities between Tc 99m tilmanocept and unfiltered Tc 99m sulfur colloid.
Time frame: 5 days after Tc 99m tilmanocept injection
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