Safety Evaluation of IV Tc 99m Tilmanocept and Comparison of Imaging With Sulfur Colloid in Subjects With and Without NASH
NCT ID: NCT03332940
Last Updated: 2024-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
PHASE1
6 participants
INTERVENTIONAL
2017-12-06
2019-03-10
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
This study is designed to evaluate the safety and tolerability of Tc99m-tilmanocept in subjects with NASH.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
SEQUENTIAL
DIAGNOSTIC
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
NASH subjects
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.
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.
Tc99m-tilmanocept
Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface.
Healthy controls
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.
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.
Tc99m-tilmanocept
Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Tc99m-tilmanocept
Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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.
18 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Navidea Biopharmaceuticals
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Michael Blue, MD
Role: STUDY_DIRECTOR
Navidea Biopharmaceuticals, Inc.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Kettering Medical Center
Kettering, Ohio, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Cope FO, Abbruzzese B, Sanders J, Metz W, Sturms K, Ralph D, Blue M, Zhang J, Bracci P, Bshara W, Behr S, Maurer T, Williams K, Walker J, Beverly A, Blay B, Damughatla A, Larsen M, Mountain C, Neylon E, Parcel K, Raghuraman K, Ricks K, Rose L, Sivakumar A, Streck N, Wang B, Wasco C, Williams A, Schlesinger LS, Azad A, Rajaram MVS, Jarjour W, Young N, Rosol T, McGrath M. Corrigendum to the inextricable axis of targeted diagnostic imaging and therapy: An immunological natural history approach [Nucl Med Biol 43 (2016) 215-225]. Nucl Med Biol. 2016 Dec;43(12):837. doi: 10.1016/j.nucmedbio.2016.10.001. No abstract available.
Cope, F.O., W. Metz, et al. Innovations in receptor-targeted precision imaging at Navidea: diagnosis up close and personal. Nature Outlook (31 October 2013); S125-S129.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol and Statistical Analysis Plan
Related Links
Access external resources that provide additional context or updates about the study.
Navidea Biopharmaceuticals, Inc.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
NAV3-30
Identifier Type: -
Identifier Source: org_study_id