An Evaluation of the Safety of Intravenous Tc 99m Tilmanocept and a Comparison of Imaging With Sulfur Colloid in Subjects With and Without NASH
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|ClinicalTrials.gov Identifier: NCT03332940|
Recruitment Status : Recruiting
First Posted : November 6, 2017
Last Update Posted : May 9, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Nonalcoholic Steatohepatitis NASH - Nonalcoholic Steatohepatitis||Drug: Tc 99M Sulfur Colloid Drug: Tc99m-tilmanocept||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||12 participants|
|Intervention Model:||Sequential Assignment|
|Masking:||None (Open Label)|
|Official Title:||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)|
|Actual Study Start Date :||December 6, 2017|
|Estimated Primary Completion Date :||June 2018|
|Estimated Study Completion Date :||September 2018|
Experimental: Tc99m-sulfur colloid + Tc99m-tilmanocept
All subjects will receive a single IV injection of unfiltered sulfur colloid radiolabeled with 8 mCi Tc99m on study day 0. All subjects will receive a single IV injection of 200 mcg tilmanocept radiolabeled with 8 mCi Tc99m on study day 3.
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.
Other Name: Sulfur colloid
Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface.
- Adverse Drug Reaction [ Time Frame: 5 days after Tc 99m tilmanocept injection ]Proportion of subjects experiencing noxious pharmacologic activity/an Adverse Drug Reaction (ADR).
- Localization of Tc 99m tilmanocept [ Time Frame: 5 days after Tc 99m tilmanocept injection ]Determine the three dimensional tessellation localization of Tc 99m tilmanocept by planar and SPECT/CT imaging in subjects with NASH and asymptomatic controls.
- Localization of Tc 99m sulfur colloid [ Time Frame: 5 days after Tc 99m tilmanocept injection ]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.
- Localization Distribution Comparison [ Time Frame: 5 days after Tc 99m tilmanocept injection ]Comparison of liver localization distribution tessellation pattern intensities between Tc 99m tilmanocept and unfiltered Tc 99m sulfur colloid.
- Tc 99m tilmanocept Localization Distribution of SPECT/CT vs Elastography [ Time Frame: 5 days after Tc 99m tilmanocept injection ]Concordance of intrahepatic localization tessellation discrimination of Tc 99m tilmanocept (intrahepatic disease heterogeneity) by SPECT/CT imaging and elastography.
- Tc 99m sulfur colloid Localization Distribution of SPECT/CT vs Elastography [ Time Frame: 5 days after Tc 99m tilmanocept injection ]Concordance of intrahepatic localization tessellation discrimination of Tc 99m sulfur colloid (intrahepatic disease heterogeneity) by SPECT/CT imaging and elastography.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03332940
|Contact: Rachael Hersheyemail@example.com|
|Contact: Fred Cope, PhDfirstname.lastname@example.org|
|United States, Ohio|
|Kettering Medical Center||Recruiting|
|Kettering, Ohio, United States, 45429|
|Contact: Mary Connolly, PhD 937-395-8227 Mary.Connolly@ketteringhealth.org|
|Contact: Kelly Keeton 937-395-8364 Kelly.Keeton@ketteringhealth.org|
|Principal Investigator: Arash Kardan, MD|
|Study Director:||Michael Blue, MD||Navidea Biopharmaceuticals, Inc.|