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

• Status: Terminated
• Trial end date: 2017-07-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cardinal Health 414, LLC; Navidea Biopharmaceuticals
• Treatments: Dextrans; Technetium Tc 99m Pentetate

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