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Development of a Normative Database for Rheumatoid Arthritis (RA) Imaging With Tc99m Tilmanocept | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Development of a Normative Database for Rheumatoid Arthritis (RA) Imaging With Tc99m Tilmanocept

NCT04947137•Navidea Biopharmaceuticals

View on ClinicalTrials.gov

Summary

This study will establish a normative database of Tilmanocept Uptake Values (TUVjoint) in healthy controls age-matched to the RA population.

Detailed Description

This is a prospective, open-label, multicenter, single-dose study designed to develop a normative database of TUVjoint in HCs and to assess the feasibility of qualitative and quantitative SPECT/CT assessments in HCs and subjects with active RA. This study is stratified into 2 arms. Arm 1 is comprised of HCs and Arm 2 is comprised of HCs and clinically diagnosed RA subjects on stable treatment.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Yes

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 has agreed to not engage in any diet, lifestyle, or medication changes until study completion.
•HEALTHY CONTROL SUBJECTS
•3. The subject is 30 years of age or greater at the time of consent.
•4. The subject is deemed to be clinically free of any inflammatory disease(s), autoimmune disease(s), or arthropathies and has not experienced joint pain for at least 28 days prior to the consent date.
•5. The subject is not currently on anti-inflammatory drugs (including non-steroidal anti-inflammatory drugs \[NSAIDs\]) and has not taken any anti-inflammatories for at least 28 days prior to the consent date.
•6. For all ongoing concomitant medications, the subject has maintained a stable dose for at least 28 days prior to the consent date.
•CLINICALLY DIAGNOSED ACTIVE RA SUBJECTS
•3\. The subject is at least 18 years of age and was ≥ 18 years of age at the time of RA diagnosis.
+3 more criteria

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 is currently receiving radiation therapy or chemotherapy or has received radiation therapy or chemotherapy in the past six months.
•4. The subject has had a finger, hand, and/or wrist amputation or hand or wrist joint arthroplasty.
•5. The subject has renal insufficiency as demonstrated by a glomerular filtration rate of \< 60 mL/min.
•6. The subject has hepatic insufficiency as demonstrated by ALT (alanine aminotransferase \[SGPT\]) or AST (aspartate aminotransferase \[SGOT\]) greater than 2 times the upper limit of normal.
•7. The subject has any severe, acute, or chronic medical conditions and/or psychiatric conditions and/or laboratory abnormalities that would impart, in the judgment of the investigator, excess risk associated with study participation or study drug administration that would deem the subject inappropriate for study participation or compromise the safety of the subject or the quality of the data.
•8. The subject has any unstable medical illnesses, including hepatic, renal, gastroenterologic, cardiovascular (including ischemic heart disease), endocrinologic, neurologic, immunologic, or hematologic disease.
•9. The subject has a known allergy to or has had an adverse reaction to dextran exposure.
•10. The subject has received an investigational product within 30 days prior to Tc 99m tilmanocept administration (Day 0).
+3 more criteria

Locations (7)

San Marcus Research Clinic

Miami Lakes, Florida, United States

Innovation Medical Research Center

Palmetto Bay, Florida, United States

Kettering Medical Center

Kettering, Ohio, United States

Essential Medical Research

Tulsa, Oklahoma, United States

Altoona Center for Clinical Research

Duncansville, Pennsylvania, United States

Sun Research Institute

San Antonio, Texas, United States

Tranquility Research

Webster, Texas, United States

Key Dates

Start Date

May 27, 2021

Primary Completion Date

January 21, 2022

Completion Date

January 21, 2022

Last Updated

January 8, 2025

Enrollment

134

ACTUAL participants

Conditions

Rheumatoid Arthritis

Interventions

Tc99m tilmanocept

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 8, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Development of a Normative Database for Rheumatoid Arthritis (RA) Imaging With Tc99m Tilmanocept

Inclusion Criteria

Exclusion Criteria

Clinical Cohort Construction and Therapeutic Effect Evaluation of Integrated Traditional Chinese and Western Medicine in the Treatment of Rheumatoid Arthritis

A Study to Evaluate the Safety and Activity of SAR448501/DR-0201 in Patients With Autoimmune Rheumatic Diseases

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