Ignite Creation Date:
2024-05-06 @ 10:42 AM
Last Modification Date:
2024-10-26 @ 12:34 PM
Study NCT ID:
NCT03332940
Status:
COMPLETED
Last Update Posted:
2019-03-21
First Post:
2017-11-01
Brief Title:
An Evaluation of the Safety of Intravenous Tc 99m Tilmanocept and a Comparison of Imaging With Sulfur Colloid in Subjects With and Without NASH
Sponsor:
Navidea Biopharmaceuticals
Organization:
Navidea Biopharmaceuticals
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2019-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 SPECTCT imaging
This study is designed to evaluate the safety and tolerability of Tc99m-tilmanocept in subjects with NASH
This study is designed to evaluate the safety and tolerability of Tc99m-tilmanocept in subjects with NASH
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None