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An Evaluation of the Safety of Intravenous Tc 99m Tilmanocept and a Comparison of Imaging With Sulfur Colloid in Subjects With and Without NASH

This study is not yet open for participant recruitment.
Verified November 2017 by Navidea Biopharmaceuticals
Sponsor:
ClinicalTrials.gov Identifier:
NCT03332940
First Posted: November 6, 2017
Last Update Posted: November 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Navidea Biopharmaceuticals
  Purpose

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 Intervention Phase
Nonalcoholic Steatohepatitis NASH - Nonalcoholic Steatohepatitis Drug: Tc 99M Sulfur Colloid Drug: Tc99m-tilmanocept Phase 1

Study Type: Interventional
Study Design: Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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)

Resource links provided by NLM:


Further study details as provided by Navidea Biopharmaceuticals:

Primary Outcome Measures:
  • Adverse Drug Reaction [ Time Frame: 5 days after Tc 99m tilmanocept injection ]
    Proportion of subjects experiencing noxious pharmacologic activity/an Adverse Drug Reaction (ADR).


Secondary Outcome Measures:
  • 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.


Other Outcome Measures:
  • 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.


Estimated Enrollment: 11
Anticipated Study Start Date: November 2017
Estimated Study Completion Date: July 2018
Estimated Primary Completion Date: April 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Drug: Tc99m-tilmanocept
Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface.
Other Names:
  • Tilmanocept
  • Lymphoseek

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • ALL SUBJECTS:

    1. The subject has provided written informed consent with HIPAA (Health Information Portability and Accountability Act) authorization before the initiation of any study-related procedures.
    2. The subject is ≥18 years of age at the time of consent.
    3. The subject has a body mass index (BMI) between 18 and 45.

      CONTROL SUBJECTS:

    4. The subject is deemed to be clinically free of any infectious/inflammatory disease(s) for at least 4 weeks prior to the consent date.
    5. The subject has not taken any antibiotics for at least 4 weeks prior to the consent date.

NASH SUBJECTS:

4. The subject has biopsy-confirmed NASH within 12 months prior to enrollment. 5. The subject has a NAFLD Activity Score (NAS) of ≥ 4, with a score of at least 1 for each steatosis, lobular inflammation, and hepatocyte ballooning.

6. The subject has fibrosis staging of F3-F4.

Exclusion Criteria:

  • ALL SUBJECTS:

    1. The subject is pregnant or lactating.
    2. The subject size or weight is not compatible with imaging per the investigator.
    3. The subject has received radiation therapy or chemotherapy or has a previous diagnosis of cancer other than basal cell carcinoma.
    4. The subject has renal insufficiency as demonstrated by a GFR of < 60 mL/min.
    5. The subject has a chronic or persistent infection or has any condition that would, in the opinion of the examining physician, preclude their participation.
    6. The subject has a known allergy to or has had an adverse reaction to dextran exposure.
    7. The subject has received an investigational product within 30 days prior to the Tc 99m sulfur colloid administration.
    8. The subject has received any radiopharmaceutical within 7 days prior to the administration of Tc 99m sulfur colloid.
    9. The subject is HIV positive.
    10. The subject has a history of alcohol abuse or currently consumes alcohol in excess of 3 drinks/day for men or 2 drinks/day for women.
    11. The subject has hepatitis B or C.

      CONTROL SUBJECTS:

    12. The subject has hepatic insufficiency as demonstrated by ALT (alanine aminotransferase [SGPT]) or AST (aspartate aminotransferase [SGOT]) greater than two times the upper limit of normal (ULN).
    13. The subject has been diagnosed with NASH, NAFLD, or other chronic liver disease.
    14. The subject has been diagnosed with metabolic syndrome or Type I or II diabetes.

NASH SUBJECTS:

12. The subject has any chronic liver disease aside from NASH/NAFLD. 13. The subject has uncontrolled diabetes as indicated by an A1c >9% within the 3 months prior to enrollment.

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03332940


Contacts
Contact: Bonnie Abbruzzese 614-822-2327 babbruzzese@navidea.com
Contact: Fred Cope, PhD 614-822-2320 fcope@navidea.com

Sponsors and Collaborators
Navidea Biopharmaceuticals
Investigators
Study Director: Fred Cope, PhD Navidea Biopharmaceuticals, Inc.
  More Information

Additional Information:
Publications:
Responsible Party: Navidea Biopharmaceuticals
ClinicalTrials.gov Identifier: NCT03332940     History of Changes
Other Study ID Numbers: NAV3-30
First Submitted: November 1, 2017
First Posted: November 6, 2017
Last Update Posted: November 6, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Navidea Biopharmaceuticals:
Tc99m-tilmanocept
Tilmanocept
NASH
Nonalcoholic Steatohepatitis

Additional relevant MeSH terms:
Fatty Liver
Non-alcoholic Fatty Liver Disease
Liver Diseases
Digestive System Diseases
Technetium Tc 99m Sulfur Colloid
Radiopharmaceuticals
Molecular Mechanisms of Pharmacological Action