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.
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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