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

Study Overview
=================
Brief 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.

Official Title
-----------------
A Prospective, Open-Label 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

Conditions
-----------------
Uterine Cervical Neoplasms

Intervention / Treatment
-----------------
* Drug: Tc99m tilmanocept


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject has provided written informed consent with HIPAA authorization Has cervical cancer and is a candidate for surgical intervention, with lymph node dissection being a part of the surgical plan. Is at least 18 years of age at the time of consent Has an ECOG performance status of Grade 0 to 2 Has the following International Federation of Gynecology and Obstetrics (FIGO) IA2-IIA1staging. Subjects with a single enlarged/suspicious node on PET/CT will still be considered eligible as consistent with FIGO guidelines. If of childbearing potential, the subject has a negative pregnancy test within 48 hours before administration of Lymphoseek, has been surgically sterilized, or has been postmenopausal for at least 1 year Exclusion Criteria: The subject has had preoperative chemotherapy, immunotherapy, or radiation therapy within the 30 days prior to Lymphoseek administration Has had previous surgery or radiation to node basins that would be involved in the ILM procedure Has a known allergy to dextran Is breast-feeding or pregnant Before the administration of Lymphoseek, has received any radiopharmaceutical within 7 radioactive half-lives of that radiopharmaceutical Is scheduled for surgery and/or another invasive procedure other than the primary surgical intervention within the 3 days after Lymphoseek administration Has received an investigational product within the 30 days prior to Lymphoseek administration

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tc99m tilmanocept<br>2 mCi (74 MBq), 50 ug of Tc99M tilmanocept single administration | Drug: Tc99m tilmanocept<br>* A single dose of 2 mCi (74 MBq) and 50 ug of Tc99m tilmanocept administered peritumorally no more than 20 hours before surgery<br>* Other names: Lymphoseek;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Per-subject False Negative Rate | Proportion of subjects with pathologically negative Lymphoseek-identified SLNs and at least one pathologically positive non-SLN | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Per-subject Sensitivity | Proportion of subjects with at least one pathologically positive Lymphoseek-identified SLN that have at least one pathologically positive lymph node | 1 day | 
| Per-subject Negative Predictive Value | Proportion of subjects with pathologically negative Lymphoseek-identified SLN(s) with no pathologically positive lymph nodes | 1 day | 
| Per-subject Accuracy | Proportion of subjects accurately indentified by Lymphoseek | 1 day | 
| Proportion of Lymph Nodes Identified Intraoperatively by a Dye That Are Also Identified by Lymphoseek |  | 1 day | 
| Number of Lymph Nodes Per-subject Identified by Lymphoseek |  | 1 day | 
| Number of Lymph Nodes Per-subject Identified by Other Dyes |  | 1 day | 
| Per-subject Concordance | Subjects whose lymph nodes were determined to be dye positive that were also identified by Lymphoseek | 1 day | 
| Per-subject Reverse Concordance | Number of subjects whose lymph nodes that were identified by Lymphoseek were also all identified by dye | 1 day | 
| Incidence of Adverse Events |  | 7 days |