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NCT03332940 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study, sponsored by Navidea Biopharmaceuticals.

Terminated
Registry status
Phase 1
Development phase
6
Enrollment target

NCT03332940: Clinical Trial Phase 1 study, sponsored by Navidea Biopharmaceuticals.

NCT03332940 is a Phase 1 study that was terminated before completion, run by Navidea Biopharmaceuticals. The registered enrollment target is 6 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03332940, a Phase 1 study, was terminated before completion, sponsored by Navidea Biopharmaceuticals.

TERMINATED
Registry status
Phase 1
Development phase
6 participants
Enrollment target

Study 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.

Primary Outcome

Proportion of subjects experiencing noxious pharmacologic activity/an Adverse Drug Reaction (ADR).

Interventions

  • DRUG Tc99m-tilmanocept
  • DRUG Tc 99M Sulfur Colloid

Trial Details

FieldValue
Enrollment Target 6 participants
Start Date 2017-12-06
Est. Completion 2019-03-10
Phase Phase 1
Navidea Biopharmaceuticals

15 total trials

Why NCT03332940 stopped before completion

NCT03332940 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (90% lower).

The record links to 0 conditions, and to 2 interventions - of which Tc99m-tilmanocept is the first listed.

NCT03332940 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03332940 about?

NCT03332940 is a clinical study titled "Safety Evaluation of IV Tc 99m Tilmanocept and Comparison of Imaging With Sulfur Colloid in Subjects With and Without NASH". 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 nonalcohol...

What is the current status of trial NCT03332940?

This trial is currently terminated. It is a Phase 1 study. The enrollment target is 6 participants. The study started on 2017-12-06. Estimated completion is 2019-03-10.

What interventions are being tested in trial NCT03332940?

The interventions under investigation include: Tc99m-tilmanocept (DRUG), Tc 99M Sulfur Colloid (DRUG).

Who is sponsoring clinical trial NCT03332940?

This trial is sponsored by Navidea Biopharmaceuticals, which has 15 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03332940's enrollment target sits among peer trials

6 1974th of 2000 higher than 12 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03332940, the US trial registry maintained by the National Library of Medicine. NCT03332940 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.