| Primary | Per-subject False Negative Rate | Proportion of subjects with pathologically negative Lymphoseek-identified SLNs and at least one pathologically positive non-SLN | Participants receiving a single dose of 50 µg Lymphoseek radiolabeled with 2 mCi (74 MBq) Tc 99m for whom at least one lymph node was removed with histopathology available | Posted | | Number | 95% Confidence Interval | Proportion of Participants | | 1 day | | | | ID | Title | Description |
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| OG000 | Intent-To-Treat | 2 mCi (74 MBq), 50 ug of Tc99M tilmanocept single administration Tc99m tilmanocept: A single dose of 2 mCi (74 MBq) and 50 ug of Tc99m tilmanocept administered peritumorally no more than 20 hours before surgery |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG000.333(.0084 to .9057)
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| Secondary | Per-subject Sensitivity | Proportion of subjects with at least one pathologically positive Lymphoseek-identified SLN that have at least one pathologically positive lymph node | Participants receiving a single dose of 50 µg Lymphoseek radiolabeled with 2 mCi (74 MBq) Tc 99m for whom at least one lymph node was removed with histopathology available | Posted | | Number | 95% Confidence Interval | Proportion of participants | | 1 day | | | | ID | Title | Description |
|---|
| OG000 | Intent-To-Treat | 2 mCi (74 MBq), 50 ug of Tc99M tilmanocept single administration Tc99m tilmanocept: A single dose of 2 mCi (74 MBq) and 50 ug of Tc99m tilmanocept administered peritumorally no more than 20 hours before surgery |
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| Secondary | Per-subject Negative Predictive Value | Proportion of subjects with pathologically negative Lymphoseek-identified SLN(s) with no pathologically positive lymph nodes | Participants receiving a single dose of 50 µg Lymphoseek radiolabeled with 2 mCi (74 MBq) Tc 99m for whom at least one lymph node was removed with histopathology available | Posted | | Number | 95% Confidence Interval | Proportion of participants | | 1 day | | | | ID | Title | Description |
|---|
| OG000 | Intent-To-Treat | 2 mCi (74 MBq), 50 ug of Tc99M tilmanocept single administration Tc99m tilmanocept: A single dose of 2 mCi (74 MBq) and 50 ug of Tc99m tilmanocept administered peritumorally no more than 20 hours before surgery |
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| Secondary | Per-subject Accuracy | Proportion of subjects accurately indentified by Lymphoseek | Participants receiving a single dose of 50 µg Lymphoseek radiolabeled with 2 mCi (74 MBq) Tc 99m for whom at least one lymph node was removed with histopathology available | Posted | | Number | 95% Confidence Interval | Proportion of participants | | 1 day | | | | ID | Title | Description |
|---|
| OG000 | Intent-To-Treat | 2 mCi (74 MBq), 50 ug of Tc99M tilmanocept single administration Tc99m tilmanocept: A single dose of 2 mCi (74 MBq) and 50 ug of Tc99m tilmanocept administered peritumorally no more than 20 hours before surgery |
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| Secondary | Proportion of Lymph Nodes Identified Intraoperatively by a Dye That Are Also Identified by Lymphoseek | | Participants receiving a single dose of 50 µg Lymphoseek radiolabeled with 2 mCi (74 MBq) Tc 99m for whom at least one lymph node was removed with histopathology available | Posted | | Number | 95% Confidence Interval | Proportion of Condordant Nodes | | 1 day | Dye Positive Nodes | Dye Positive Nodes | | ID | Title | Description |
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| OG000 | Intent-To-Treat | 2 mCi (74 MBq), 50 ug of Tc99M tilmanocept single administration Tc99m tilmanocept: A single dose of 2 mCi (74 MBq) and 50 ug of Tc99m tilmanocept administered peritumorally no more than 20 hours before surgery |
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| Secondary | Number of Lymph Nodes Per-subject Identified by Lymphoseek | | Participants receiving a single dose of 50 µg Lymphoseek radiolabeled with 2 mCi (74 MBq) Tc 99m for whom at least one lymph node was removed with histopathology available | Posted | | Mean | 95% Confidence Interval | Nodes Per Subject | | 1 day | Total Lymph Nodes | Total Lymph Nodes | | ID | Title | Description |
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| OG000 | Intent-To-Treat | 2 mCi (74 MBq), 50 ug of Tc99M tilmanocept single administration Tc99m tilmanocept: A single dose of 2 mCi (74 MBq) and 50 ug of Tc99m tilmanocept administered peritumorally no more than 20 hours before surgery |
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| Secondary | Number of Lymph Nodes Per-subject Identified by Other Dyes | | | Posted | | Mean | 95% Confidence Interval | Nodes Per Subject | | 1 day | Total Lymph Nodes | Total Lymph Nodes | | ID | Title | Description |
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| OG000 | Intent-To-Treat | 2 mCi (74 MBq), 50 ug of Tc99M tilmanocept single administration Tc99m tilmanocept: A single dose of 2 mCi (74 MBq) and 50 ug of Tc99m tilmanocept administered peritumorally no more than 20 hours before surgery |
| | Units | Counts |
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| Participants | | | Total Lymph Nodes | |
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| Secondary | Per-subject Concordance | Subjects whose lymph nodes were determined to be dye positive that were also identified by Lymphoseek | Participants receiving a single dose of 50 µg Lymphoseek radiolabeled with 2 mCi (74 MBq) Tc 99m for whom at least one lymph node was removed with histopathology available | Posted | | Number | 95% Confidence Interval | Proportion of Condordant Subjects | | 1 day | Dye Positive Nodes | Dye Positive Nodes | | ID | Title | Description |
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| OG000 | Intent-To-Treat | 2 mCi (74 MBq), 50 ug of Tc99M tilmanocept single administration Tc99m tilmanocept: A single dose of 2 mCi (74 MBq) and 50 ug of Tc99m tilmanocept administered peritumorally no more than 20 hours before surgery |
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| Secondary | Per-subject Reverse Concordance | Number of subjects whose lymph nodes that were identified by Lymphoseek were also all identified by dye | Participants receiving a single dose of 50 µg Lymphoseek radiolabeled with 2 mCi (74 MBq) Tc 99m for whom at least one lymph node was removed with histopathology available | Posted | | Number | 95% Confidence Interval | Proportion of Reverse Condordant Subj. | | 1 day | Hot Positive Nodes | Hot Positive Nodes | | ID | Title | Description |
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| OG000 | Intent-To-Treat | 2 mCi (74 MBq), 50 ug of Tc99M tilmanocept single administration Tc99m tilmanocept: A single dose of 2 mCi (74 MBq) and 50 ug of Tc99m tilmanocept administered peritumorally no more than 20 hours before surgery |
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| Secondary | Incidence of Adverse Events | | Enrolled subjects who were administered any injection of Tc99m tilmanocept. | Posted | | Number | | Events | | 7 days | | | | ID | Title | Description |
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| OG000 | Tc99m Tilmanocept | Enrolled patients who were administered any injection of Lymphoseek. |
| | | Title | Denominators | Categories |
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