Prospective, open-label, within-patient, multi-center study of Lymphoseek in the detection of lymph nodes in subjects with known cancer of the cervix. All subjects will receive a single dose of 50 µg Lymphoseek radiolabeled with 2 mCi (74 MBq) Tc 99m.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
18
A single dose of 2 mCi (74 MBq) and 50 ug of Tc99m tilmanocept administered peritumorally no more than 20 hours before surgery
University of California, San Diego
La Jolla, California, United States
Sylvester Comprehensive Cancer Center
Miami, Florida, United States
Wake Forest Baptist Health
Winston-Salem, North Carolina, United States
The University of Texas M.D. Anderson Cancer Center
Houston, Texas, United States
Per-subject False Negative Rate
Proportion of subjects with pathologically negative Lymphoseek-identified SLNs and at least one pathologically positive non-SLN
Time frame: 1 day
Per-subject Sensitivity
Proportion of subjects with at least one pathologically positive Lymphoseek-identified SLN that have at least one pathologically positive lymph node
Time frame: 1 day
Per-subject Negative Predictive Value
Proportion of subjects with pathologically negative Lymphoseek-identified SLN(s) with no pathologically positive lymph nodes
Time frame: 1 day
Per-subject Accuracy
Proportion of subjects accurately indentified by Lymphoseek
Time frame: 1 day
Proportion of Lymph Nodes Identified Intraoperatively by a Dye That Are Also Identified by Lymphoseek
Time frame: 1 day
Number of Lymph Nodes Per-subject Identified by Lymphoseek
Time frame: 1 day
Number of Lymph Nodes Per-subject Identified by Other Dyes
Time frame: 1 day
Per-subject Concordance
Subjects whose lymph nodes were determined to be dye positive that were also identified by Lymphoseek
Time frame: 1 day
Per-subject Reverse Concordance
Number of subjects whose lymph nodes that were identified by Lymphoseek were also all identified by dye
Time frame: 1 day
Incidence of Adverse Events
Time frame: 7 days
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