drugset / Trial / NCT02509585

A Trial of Comparing the Pathology Status of Lymphoseek®-Identified Sentinel Lymph Nodes Relative to the Pathological Pathology Status of Nonsentinel Lymph Nodes in Nodal Staging of Subjects With Known Cancer of the Cervix Who Are Undergoing Lymph Node Dissection

NCT02509585

Phase 2 Terminated 18 enrolled Cardinal Health 414, LLC
NaSingle-groupOpen-labelDiagnostic

Summary

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.

Timeline

Start
2016-01
Primary completion
2017-07
Completion
2017-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Technetium Tc 99m Tilmanocept Diagnostic / imaging agent 50 ug Other
Subject Technetium Tc 99m Tilmanocept Diagnostic / imaging agent 74 mbq Other