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
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Keep this study
Lead
Cardinal Health 414, LLC
Age
18–any
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
Clareo Health | 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
