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This study was combined with another trial that was on-going.
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A prospective, open-label, single center, study to evaluate pharmacokinetics and dosimetry of intravenously injected Tc 99m tilmanocept at three mass doses (50 µg, 200 µg, and 400 µg) radiolabeled with 10 millicuries (mCi) Tc 99m.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 50 ug Tilmanocept | Experimental | Single dose of 50 ug tilmanocept radiolabeled with 10 mCi technetium Tc99m |
|
| 200 ug Tilmanocept | Experimental | Single dose of 200 ug tilmanocept radiolabeled with 10 mCi technetium Tc99m |
|
| 400 ug Tilmanocept | Experimental | Single dose of 400 ug tilmanocept radiolabeled with 10 mCi technetium Tc99m |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tilmanocept | Drug | Intravenously administered Technetium Tc 99m tilmanocept |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Plasma concentration (Cmax) of Technetium Tc 99m Tilmanocept | Maximum Plasma concentration (Cmax) of Technetium Tc 99m Tilmanocept | 1 Days |
| Plasma Area Under the Curve (AUC) of Technetium Tc 99m Tilmanocept | Plasma Area Under the Curve (AUC) of Technetium Tc 99m Tilmanocept | 2 Days |
| Systemic Clearance (CLs) of Technetium Tc 99m Tilmanocept | Systemic Clearance (CLs) of Technetium Tc 99m Tilmanocept | 3 Days |
| Renal Clearance (CLr) of Technetium Tc 99m Tilmanocept | Renal Clearance (CLr) of Technetium Tc 99m Tilmanocept | 2 days |
| Terminal Elimination Half-Life (T1/2) of Technetium Tc 99m Tilmanocept | Terminal Elimination Half-Life (T1/2) of Technetium Tc 99m Tilmanocept | 3 days |
| Clinical Dosimetry of Technetium Tc 99m Tilmanocept | Clinical Dosimetry of Technetium Tc 99m Tilmanocept | 3 days |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Adverse Events | Incidence of Adverse Events | 7 Days |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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