Status:
TERMINATED
Safety Evaluation of IV Tc 99m Tilmanocept and Comparison of Imaging With Sulfur Colloid in Subjects With and Without NASH
Lead Sponsor:
Navidea Biopharmaceuticals
Conditions:
Nonalcoholic Steatohepatitis
NASH - Nonalcoholic Steatohepatitis
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 dimension...
Eligibility Criteria
Inclusion
- ALL SUBJECTS:
- The subject has provided written informed consent with HIPAA (Health Information Portability and Accountability Act) authorization before the initiation of any study-related procedures.
- The subject is ≥18 years of age at the time of consent.
- The subject has a body mass index (BMI) between 18 and 45.
- CONTROL SUBJECTS:
- The subject is deemed to be clinically free of any infectious/inflammatory disease(s) for at least 4 weeks prior to the consent date.
- 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
- ALL SUBJECTS:
- The subject is pregnant or lactating.
- The subject size or weight is not compatible with imaging per the investigator.
- The subject has received radiation therapy or chemotherapy or has a previous diagnosis of cancer other than basal cell carcinoma.
- The subject has renal insufficiency as demonstrated by a GFR of \< 60 mL/min.
- The subject has a chronic or persistent infection or has any condition that would, in the opinion of the examining physician, preclude their participation.
- The subject has a known allergy to or has had an adverse reaction to dextran exposure.
- The subject has received an investigational product within 30 days prior to the Tc 99m sulfur colloid administration.
- The subject has received any radiopharmaceutical within 7 days prior to the administration of Tc 99m sulfur colloid.
- The subject is HIV positive.
- 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.
- The subject has hepatitis B or C.
- CONTROL SUBJECTS:
- 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).
- The subject has been diagnosed with NASH, NAFLD, or other chronic liver disease.
- 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.
Key Trial Info
Start Date :
December 6 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 10 2019
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT03332940
Start Date
December 6 2017
End Date
March 10 2019
Last Update
December 24 2024
Active Locations (1)
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1
Kettering Medical Center
Kettering, Ohio, United States, 45429