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

Phase 2

Terminated

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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Tc99m tilmanocept	Tc99m tilmanocept	2 mCi (74 MBq), 50 ug of Tc99M tilmanocept single administration

Primary Outcome Measures

Name	Time	Method
Per-subject False Negative Rate	1 day	Proportion of subjects with pathologically negative Lymphoseek-identified SLNs and at least one pathologically positive non-SLN

Secondary Outcome Measures

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

Locations (4): University of California, San Diego
🇺🇸
La Jolla, California, United States
Sylvester Comprehensive Cancer Center
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Miami, Florida, United States
Wake Forest Baptist Health
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Winston-Salem, North Carolina, United States
The University of Texas M.D. Anderson Cancer Center
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Houston, Texas, United States