NAV3-32
Research type
Research Study
Full title
A Comparison of Tc 99m Tilmanocept Quantitative Imaging with Immunohistochemical (IHC) Analysis of CD206 Expression in Synovial Tissue from Subjects Clinically Diagnosed with Rheumatoid Arthritis (RA)
IRAS ID
269022
Contact name
William Regan
Contact email
Sponsor organisation
Navidea Biopharmaceuticals Ltd
Eudract number
2018-003418-41
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
Research Summary
Rheumatoid arthritis (RA) is a chronic, disabling autoimmune condition in which the body attacks itself, that predominantly impacts the joints. Approximately 24 adult patients with active RA undergoing treatment will be recruited. In the UK patients will be recruited from NHS sites. Participants will undergo a full body scan & a biopsy of a single joint.\n\nThe number & types of cells (pathology) present in RA inflamed joints vary between patients & there is growing evidence that patients with different RA pathologies respond differently to various therapies. By knowing the pathology of patients’ RA joints, decisions on the types of treatment can be made that could potentially maximize the probability of a positive response. Currently the only way of knowing the pathology of a patients joints is to biopsy each joint.\n\nThe aim is to compare the results of an imaging scan performed after administration of technetium-99m tilmanocept (Lymphoseek®) to the results of a biopsy in order to determine the pathology of the joints. \n\nThere are several reasons why imaging may be preferred to biopsies for evaluation of RA patients: \n1. Biopsy procedures usually only target a single joint, whereas imaging can provide an assessment of all joints.\n2. Biopsies are only performed on patients with a sufficiently inflamed joint to allow for sufficient tissue to be collected for analysis. This could be a problem when evaluating patients in the early phase of symptomatic RA.\n3. When a biopsy is performed it is not guaranteed that the sample collected will be of sufficient quantity or quality for analysis.\n4. There are limitations to how many biopsies can be performed on an individual joint, & there is a risk of biopsy related trauma. \n5. Performing biopsies is challenging & requires extensive training. Currently they are not routinely performed in NHS practice.\n
Summary of Results
Note: Available data from this trial are being presented as an abbreviated clinical study report as not all efficacy analyses were completed. Analysis of NAV3-32 trial data was halted prior to evaluation of the acquired images. Preliminary analysis of data from other trials indicated that the ability of Tc 99m tilmanocept imaging to predict response to anti-TNFα therapy in RA patients would not be sufficient for the product to be commercially viable. Therefore, further development of the product for this indication was halted.
REC name
Wales REC 3
REC reference
20/WA/0001
Date of REC Opinion
18 May 2020
REC opinion
Further Information Favourable Opinion