Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as technetium Tc 99m tilmanocept, Tilmanocept (Technetium Tc 99m tilmanocept Injection), Tc 99m tilmanocept, Tilmanocept
Lymphoseek · 3 trials · 3 indications
The proportion of lymph nodes detected intraoperatively by blue dye that were also detected by Lymphoseek.
The primary endpoint was to compare the cumulative total of anatomical zones of active RA (which were clinically defined by a swollen/tender classification during the DAS28 joint count assessment performed at baseline) with Tc 99m tilmanocept localization observed at 2-3 hours and at 4-6 hours after administration on Day 1. Tc 99m tilmanocept localization is defined by accumulation of radioactivity at an intensity greater than background, which was qualitatively determined by the central reader's visual assessment of the acquired images .
| Arm | Type | Description |
|---|---|---|
| Lymphoseek, Lymphatic mapping, Injection | EXPERIMENTAL | - |
| Cohort 1 | OTHER | Healthy Volunteers: 50 mcg tilmanocept with 2 millicuries (mCi) Tc 99m |
| Cohort 2 | OTHER | Healthy Volunteers: 200 mcg tilmanocept with 2 mCi Tc 99m |
| Cohort 3 | EXPERIMENTAL | RA Group: 50 mcg tilmanocept with 2 mCi Tc 99m |
| Cohort 4 | EXPERIMENTAL | RA group:200 mcg tilmanocept with 2 mCi Tc 99m |
| Name | Type | Description |
|---|---|---|
| Lymphoseek | DRUG | The total volume of Lymphoseek injection will be between 0.1 - 1.0 mL. |
| Tilmanocept | DRUG | - |
Inclusion Criteria: 1. The patient has provided written informed consent with HIPAA authorization. 2. The patient is a candidate for surgical intervention, with lymph node mapping being a part of the surgical plan. 3. The patient is at least 18 years of age at the time of consent. 4. The patient ha...
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