A Phase I/Phase II Study of Intravenously (IV) Administered Tc 99m Tilmanocept (TCT) to Determine Safety, Tolerability, Optimal Clinical Dose Selection, and Imaging Timepoint in Patients Clinically Diagnosed with Rheumatoid Arthritis (RA)

Conclusions: IV administration of TCT was well-tolerated and demonstrated joint-specific localization in RA subjects, revealing potentially significant immunodiagnostic information about CD206-expressing synovial macrophage involvement in RA patients. Additionally, increased TCT activity via IV administration may enhance localization and anatomic delineation in tilmanocept-positive joints of RA patients compared to SC administration studied in a prior Phase I trial. Study data analysis revealed an optimal mass dose of 134 µg of tilmanocept radiolabeled with 10 mCi Tc 99m with an imaging time frame of 1-3 hours post injection. For the purposes of accuracy and streamlining practice, a mass dose of 150 µg and imaging time frame 1-3 hours post-injection is recommended for future use. These results provide the foundation for a non-invasive method to monitor disease activity in macrophage driven inflamed joints in patients with RA. Research Support: Supported by a grant from the National Inst Arthritis & Musculoskeletal & Skin Diseases/NIH, Grant R44AR067583 ClinicalTrials.gov Identifier: NCT02683421.
Source: Journal of Nuclear Medicine - Category: Nuclear Medicine Authors: Tags: Musculoskeletal Source Type: research