NCT03332940

Safety Evaluation of IV Tc 99m Tilmanocept and Comparison of Imaging With Sulfur Colloid in Subjects With and Without NASH

An Evaluation of the Safety of Intravenous (IV) Tc 99m Tilmanocept and a Comparison of Localization to Tc 99m Sulfur Colloid in Subjects With Nonalcoholic Steatohepatitis (NASH) and Healthy Controls (HC)

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Navidea Biopharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Nonalcoholic Steatohepatitis
• NASH - Nonalcoholic Steatohepatitis

Interventions

Type	Name	Description
DRUG	Tc 99M Sulfur Colloid	Sulfur colloid is a radiotracer that is indicated for imaging areas of functional reticuloendothelial cells in the liver, spleen, and bone marrow.
DRUG	Tc99m-tilmanocept	Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface.

Timeline

• Start date: 2017-12-06
• Primary completion: 2019-03-10
• Completion: 2019-03-10
• First posted: 2017-11-06
• Last updated: 2024-12-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study